“new drugs”: drug use trends in texas today•kratom –opioid-like effects •krokodil –cheap...

Jane Maxwell, UT Addiction Research Institute, 512 232-0610

“New Drugs”:

Drug Use Trends in Texas Today

Jane Maxwell, Ph.D.

Center for Social Work Research

The University of Texas at Austin

From the terms “Spice” &

“Bath Salts” to…

2C

Phenethylamine

Psychedelics

related to

mescaline

Some were created

in the past to imitate

MDMA

Synthetic

Cathinones

Mephedrone,

methylone, 4-

MEC, MDPV,

Alpha-PVP

Stimulants related

to methcathinone,

MDMA,

amphetamines

Tryptamines

5-MeO-DMT & 4-

AcO-DMT

Psychedelics

related to psilocin

& bufotenin

Piperazines

BZP & TFMPP

Stimulants

Synthetic

Opioids

Acetyl & Butyryl

Fentanyl

U-47700

MT-45

W-18


Number of NPS reported by groups

and regions: 2008-2015

0

100

200

300

400

500

600

Africa Asia Europe North Amer.OceaniaSouth & Central Amer

Tryptamines

Synthetic cathinones

Synthetic cannabinoids

Plant-based substances

Piperazines

Phenethylamines

Other substances

Ketamine & PCP types

PCP types

Hallucinogenics

Aminoindanes

Source: UNODC Early Warning Advisory on NPS, July 2015


Emerging Synthetic Drug Threats

• Synthetic Cannabinoids

• Synthetic Cathinones (Khat)

• Phenethylamine Hallucinogens

– 2C-X (such as 2C-I, 2C-B, 2C-C)

– DOX (such as DOI, DOB, DOC)

• 25X-NBOMe (25I-NBOMe, 25B-NBOMe, 25C-

NBOMe) Placed in Schedule I in November 2013

Synthetic Opioids (UR47700)

The Synthetics: Calls to US

Poison Control Centers: 2010-2016

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

2010 2011 2012 2013 2014 2015 2016

US Syn Cannabinoids

US Syn Cathinones


Synthetic Cannabis Items Identified and

Reported to U.S. NFLIS: 2010-2016

0%

10%

20%

30%

40%

50%

60%

70%

Ax

is T

itle 2010

2011

2012

2013

2014

2015

2016

Khat

• Pronounced “cot”

• Stimulant drug derived from a shrub (Catha edulis) native to East Africa and southern Arabia

• Use is considered illegal, because one of its chemical constituents, cathinone, is a Schedule I drug

• Khat found in the U.S. often comes in by mail from Africa

SOURCE: NIDA. (2011). NIDA DrugFacts: Khat.


Synthetic Cathinone Items Identified &

Reported to U.S. NFLIS: 2000- 2016

0

10

20

30

40

50

60

70

2010 2011 2012 2013 2014 2015 2016

MDPV METHYLONE 4-MEC PENTEDRONE ALPHA-PVP ETHYLONE OTHER

Synthetic Cannabis and Cathinone Items

Identified & Reported to U.S. NFLIS:

2000- ½ 2017

Source: US NFLIS.

CANNABIS

# Seizures # Types

2010 3288 19

2011 23686 38

2012 43126 46

2013 34303 47

2014 38734 78

2015 34041 79

2016 22121 82

½2017 5848 47

CATHINONES

# Seizures # Types

2010 632 10

2011 6542 21

2012 13794 31

2013 15572 26

2014 13687 42

2015 14386 46

2016 5720 70

½ 2017 1654 39


Marijuana homolog exposures reported to

the Texas Poison Center Network during

1/1/10-5/31/17 (n=3,877)

0

20

40

60

80

100

120

Jan

-10

Ap

r-10

Ju

l-10

Oct-

10

Jan

-11

Ap

r-11

Ju

l-11

Oct-

11

Jan

-12

Ap

r-12

Ju

l-12

Oct-

12

Jan

-13

Ap

r-13

Ju

l-13

Oct-

13

Jan

-14

Ap

r-14

Ju

l-14

Oct-

14

Jan

-15

Ap

r-15

Ju

l-15

Oct-

15

Jan

-16

Nu

mb

er

Month

TX ban 9/1/11 US ban 7/9/12

Alpha-PVP (“Flakka”) Items Identified in U.S.

Forensic Labs Before and After Chinese

Banned Alpha-PVP Ingredients in October

2015

0

100

200

300

400

500

600


Changes in Synthetics

Change in Packaging

Characteristics of Clients Admitted to Texas

Treatment with Primary Problem with Cannabis vs.

Synthetic Cannabis: 2016

28 3240

69

2518

10

24 21

2

15

42 44

69

45

7 4

27

49

15

0

20

40

60

80

Cannabis Synthetic Cannabis


Source of Referral to Treatment

0.0 10.0 20.0 30.0 40.0 50.0 60.0

Family Services

Family Member

Parole

Probation

Self

Referral Agency

Syn Cannabis Cannabis All Clients

Other Drugs Currently Used at Treatment

Admission by Clients with Primary Problem with

Synthetic Cannabinoids: 2011-2016

0%

10%

20%

30%

40%

50%

No other drugs Alcohol Cannabis

2011 2012 2013 2014 2015 2016


Texas Poison Center Clinical Effects by Year:

2010-2016

0

100

200

300

400

500

2010 2011 2012 2013 2014 2015 2016

Cardio Dermal Gastro

HemeHep Misc Neuro

Exposure Site Reported on Poison Control

Cases: Texas

0%

20%

40%

60%

80%

100%

2010 2011 2012 2013 2014 2015 2016

Residence School Public Area Other/Unk


Changes in Psychoactive Substances

Identified in Forensic Laboratories in

US: 2004-2016

0

4000

8000

12000

16000

20000

24000

28000

Psilocin/Psilocybin

Tryptamines

Phenethylamines

MDMA


SOURCE: National Forensic Laboratory Information System, 2010, 2011, 2012, 2013, 2014, 2015

Glimpses of MDMA Situation in U.S.

0

5000

10000

15000

20000

25000

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

MDMA Items Identified in DEA’s NFLIS Tox Labs: 2004- 2016

MDMA


Baumann, M.H., et al. The designer methcathinone analogs, mephedrone and methylone, are substrates for

monoamine transporters in brain tissue. Neuron-psychopharmacology 37(5):1192–1203, 2011.

*http://www.ecstasydata.org/stats_su

bstance_by_year.php

Mephedrone and methylone act on the brain like MDMA


Phencyclidine

• PCP, Angel Dust, Killer Weed

• Dissolved in embalming fluid (“Fry,”

“Amp,” “Water, Water”).

• Swallowed, sniffed, smoked on joints

dipped in “Fry”.

• Out-of-body strength.

• Dissociative drug like DXM and

ketamine; effects are similar to

cathinones.

Indicators of PCP Trends in

Texas: 1998-2016

0

200

400

600

800

1000

# PCC Calls # Treatment # Tox Items Examined

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

2008 2009 2010 2011 2012 2013 2014 2015 2016


A Few Other Substances to

Throw in the Mix…

• Kratom – opioid-like effects

• Krokodil – cheap heroin replacement

• Salvia divinorum – hallucinogenic

effects

• Methoxetamine – “legal ketamine”

• Benzo Fury (5-APB) – stimulant and

hallucinogenic effects

• 2C Phenethylamines

SOURCE: Rosenbaum et al. (2012). Journal of Medical Toxicology, 8(1), 15-32.

Kratom

• Structurally similar to some hallucinogens but no hallucinogenic

activity or effects

• Acts on opioid receptors

• Not scheduled in U.S. Used by natives in SE Asia

• Some users claim it helps with detoxification

• from opioids

• Seems to be a stimulant in lower doses

– Mitragynine

• Seems to be a sedative at higher doses

– 7 hydroxymitragynine

• Often produces a mixed effect

• Onset of effects within 5 to 10 minutes of ingestion; effects last

for several hours

SOURCE: Ken Dickenson, MS, RPh, Hon DSc, July 2013 (Emerging Drug Trends 2013: Beyond Synthetics and Bath Salts).


Krokodil

• Russian cheap replacement drug for heroin made from cooking down desomorphine with gasoline, paint thinner, alcohol, iodine, red phosphorous (match heads), etc.

• In Russia, lack of clean needles and methadone, high cost of heroin, poverty, high numbers of HIV+ individuals, etc.

• No confirmed cases of desomorphine in the U.S. since 2 were identified in 2004.

• Injuries that look like krokodil can be due to shared dirty needles, bacteria, toxic adulterants, gangrene, staph infection, MRSA.

Benzo Fury• Active ingredient is 5-APB• Stimulant and hallucinogenic properties• Fairly easy to buy via the Internet, at music

festivals, and in clubs - priced at around $15 per pill.

• User-reported effects include:– Increased happiness, euphoria, extreme

mood lift, increased self-acceptance, increased intimacy, closed-eye hallucinations, increased sexual interest

SOURCE: Ken Dickenson, MS, RPh, Hon DSc, July 2013 (Emerging Drug Trends 2013: Beyond Synthetics and Bath Salts).


2C-Phenethylamines

• Almost all of the 2C-phenethylamines are produced

in Asia, principally China, but some small labs in

the U.S. are capable of producing 2C (usually 2C-

B).

• In 2011, DEA offices throughout the country began

noting the increasing availability and abuse of 2C

at raves and in nightclubs, particularly by

teenagers and young adults.

• NFLIS labs nationwide identified 253 reports of

phenethylamines in 2010, 336 in 2011, 828 in 2012,

2069 in 2013, 2186 in 2014, 1629 in 2015, 587 in

2016.

“SYRUP” in Texas▪ Codeine cough syrup (purple) and

promethazinesyrup with codeine

(green)continues to be abused.

▪ Codeine cut with Karo syrup, jolly

ranchers, and soft drink.

▪ Promethazine mixed in liter bottle

of lime or other soft drink.

▪ Google “Leaning on Syrup”


New “Relaxation” Drinks:

Drank and Lean

Valerian Roots

Melatonin

Rose Hips

“Slow Your Roll”

“Slow Motion Potion”

Legal Lean Syrup

Act - Grape Flavor

Herbal Relaxation

Supplement

• $9.95 from eBay

• Find Legal Lean

Syrup Act - Grape

Flavor Herbal

Relaxation Supplement

on eBay in the category

Health &

Beauty>Vitamins &

Dietary Supplements ...

https://www.google.com/aclk?sa=l&ai=DChcSEwiutpbjh6_VAhUEh7MKHYrpCEMYABAQGgJxbg&sig=AOD64_1yJxhC3LFJemiL8vfYqdgUp--Gjw&ctype=5&q=&ved=0ahUKEwiIiZTjh6_VAhWB2D4KHfZzAqcQ2CkIvgIwAg&adurl=


http://www.uclaisap.org/slides/synthetic-drug-training-package.html

New Issues?

• Need better way to disseminate

information on harms of new drugs.

Adults know very little about them. How

can parents talk to their kids when they

have no idea what they are talking about?

• Need information on the new and “more

potent” generation of cannabinoids and

opioids and other new drugs.

19


Jane C. Maxwell, Ph.D.

Research Professor

Addiction Research Institute

Center for Social Work Research

The University of Texas at Austin

1717 West 6th, Suite 335

Austin, Texas 78703

512 656-3361

To be posted: Google for Texas Drug Trends

8/9/2017

1

Update on

treatment

approachesCarlos F. Tirado MD, MPH, FABAMGeneral and Addiction Psychiatry

CARMA Health

ABRI Integrated Health

Restore Fx

Dripping Springs Health Care

MAP Health Management

DisclosureIndivior

Alkermes

8/9/2017

2

Outline

Principles of treatment and levels of care

Pharmacotherapies for specific

substances

Clinical characteristics and management

of acute synthetic cannabinoid and

cathinone toxicity

Behavioral therapies for Stimulants

Unifying Principles

▪ Addiction is a chronic, medical disease of the brain.

▪ Aberrant behaviors and unhealthy choices are a consequence of the acute and accumulated toxic effects of the substance on the individual

▪ Addiction resembles other chronic diseases like diabetes and heart disease in regard to genetic transmission, relapsing and remitting course and the important role of personal responsibility in determining how well the disease is controlled

▪ If you treat it as a chronic disease, you have a much better chance for staying sober and in sustained recovery from the disease

▪ People relapse because relapse or recurrence is one of the core features of this and all chronic diseases

8/9/2017

3

Incorrect assumptions about

CD treatment• Certain addictions are conditions that can be effectively

treated by “detoxification” or “drying out”.

• An episode of treatment is expected to “guarantee” long-

lasting abstinence following termination of treatment.

• If a person relapses after treatment it is often considered a

treatment “failure”.

• Treatment doesn’t work!!! BUT not one size fits all.

Treatment: Basic Elements Screening and Recognition

Treat urgent medical aspects of disease

Make the correct diagnosis (consider all

comorbidities)

Avoid negative stereotypes, judgments and

value-laden interventions

Involve family and significant others

Employ an effective behavioral treatment

Pharmacological (when available) therapies

employed as complimentary treatments to

enhance outcome

8/9/2017

4

Treatment: Levels of Care Detoxifiction/Medical Withdrawal

(outpatient or inpatient) Detox is NOT a stand alone treatment!!!

Outpatient (counseling, therapy, AA/NA, groups, intensive outpatient, partial hospital)

Residential (intensive live-in recovery oriented program). Vary widely in quality, reputation and cost.

Medical management (in conjunction with a behavioral program) - good for SUDs with pharma therapies or significant medical comorbidity.

Are all use disorders the same?

Important similarities and differences between opioids, alcohol, stimulants, cannabinoids, nicotine Withdrawal states and cravings

Risk of accidental overdose

Medical comorbidity and long term health effects

Availability of proven effective medication therapies

Relapse rates after detox or residential treatment

Psychiatric comorbidity

All respond to treatment

8/9/2017

5

Pharmacotherapy

FDA Approved Medications

Opioids

Methadone

Buprenorphine-Buprenorphine/Naloxone

Naltrexone (oral and injectable)

Not FDA approved

Ibogaine

Clonidine

Latest medication advances

Probuphine

6 month implantable buprenorphine

Each rod contains 80mg buprenorphine (4 implanted)

Stable on 8mg oral buprenorphine for at least 3 months

85.7% opioid free, sig advantage over oral (p = 0.034).

8/9/2017

6

Latest medication advances

Very Low Dose Naltrexone (methadone)

0.125mg and 0.250mg doses

Sig reductions in withdrawal sx and reduced craving

Possible additive effect with clonidine

Lofexidine (2.4mg and 3.2mg a day)

Alpha agonist (like clonidine) with more favorable cardiovascular profile

Injectable Buprenorphine in development

Pharmacotherapy


Alcohol

Naltrexone (oral and injectable)

Acamprosate

Disulfiram

Not FDA approved

Topiramate

Gabapentin

Ondansetron

8/9/2017

7

Pharmacotherapy


Nicotine

Nicotine replacement

Bupropion

Varenicline

Not FDA approved

Nortriptyline

Clonidine

Pharmacotherapy


Cannabinoids – None

Buspirone, THC substitution, valproic acid, nefazodone, bupropion, atomoxetine have been tried.

Stimulants - none

See tables

8/9/2017

8

Summary

of Cocaine

Medication

Trials

From Stoops & Rush, Exp Review Clin Pharmacology, 2014 May; 7(3): 363-374

Summary of

Amphetamine

Medication

Trials

8/9/2017

9

Cannabis vs. Cannabinoids:

Effects Seen in Clinical Cases Most symptoms are similar

to cannabis intoxication:

Tachycardia

Reddened eyes

Anxiousness

Mild sedation

Hallucinations

Acute psychosis

Memory deficits

Symptoms not typically seen

after cannabis intoxication:

Seizures

Hypertension

Nausea/vomiting

Coma

Severe agitation

Rhabdomyolysis, renal

failure

Hyperthermia

Respiratory Depression

SOURCES: Hermanns-Clausen et al. (In Press), Addiction; Rosenbaum et al. (2012). Journal of Medical Toxicology; Forrester et al. (2011). Journal of Addictive Disease; Schneir et al. (2011). Journal of Emergency Medicine.

17

Synthetic Cannabinoids: Other

Clinical Factors Overall more severe manifestations of:

Tolerance and withdrawal

Withdrawal associated seizure, tachycardia, chest pain,

palpitations, dyspnea.

Requirement for hospitalization

Psychosis and mania

Unknown how premorbid history, other substance

use interact with specific SC compounds.

SOURCE: Cooper, ZD; Adverse effects of synthetic cannabinoids: management of acute toxicity and withdrawal; Curr Psychiatry Rep (2016) 18:52

18

8/9/2017

10

Sample Clinical Treatment Protocol for Synthetic Cannabinoid Users

• Direct individual to emergency room via

ambulance

• Consult a regional Poison Control Center

• Acute management consists of:

– Supportive care with the use of benzodiazepines

and low dose neuroleptic, if needed, to control

agitation and anxiety

– Observe until resolution of abnormal vital signs,

vomiting, and psychiatric symptoms

SOURCE: Cheng, Yeo, Brown, & Regan. (2012). American Academy of Emergency Medicine, 19(2), 19-22. 19

Agitation 82%

Combative/Violent behavior 57%

Tachycardia 56%

Hallucinations 40%

Paranoia 36%

Confusion 34%

Myoclonus/Movement disorders 19%

Hypertension 17%

Chest pain 17%

CPK elevations 9%

Clinical Symptoms of Synthetic Cathinone Use in

Patients Admitted to the Emergency Department

(N=236)

SOURCE: Spiller et al. (2011). Clinical Toxicology, 49, 499-505. 20

8/9/2017

11

Sample Clinical Treatment Protocol

for Synthetic Cathinone Users

• Supportive care

• Aggressive sedation with benzodiazepines and low

dose neuroleptic (for agitation, seizures,

tachycardia, and hypertension)

• Significant hyperthemia may require passive or

active cooling.

• Lab studies including electrolytes, renal and liver

function tests, cardiac markers, and creatine kinase

should be considered.


What do you do if someone has taken a Spice Product or Bath Salts?

• Call your local poison center at 1-800-222-1222

– 57 poison centers around the country have

experts waiting to answer your call.

– Experts can help you decide whether someone

can be treated at home, or whether he or she

must go to a hospital.

• Dial 9-1-1 immediately if they:

– Stop breathing

– Collapse

– Have a seizure

SOURCE: American Association of Poison Control Centers (AAPCC). (2012). Facts about Bath Salts.

…or if they have taken one of these and are having physical symptoms or behaving in a way that is concerning to you

22

8/9/2017

12

Behavioral Treatments for

Stimulant Disorders

Community Reinforcement + Vouchers

Contingency Management

Relapse Prevention

Matrix Model

Community Reinforcement +

Vouchers

Promotes lifestyle changes in areas conducive to recovery

Marital/Couples therapy to improve primary relationship

Vocational assistance esp for high risk work

Counseling in alternative social and recreational practices

Individualized skills training (social, mood regulation, time management)

MAT for co-occurring substances.

8/9/2017

13

Contingency Management

Increase or decrease behaviors by providing immediate reinforcing or punishing behaviors when target behavior occurs.

Usually linked to negative UDSs and level of program adherence

Incentives are usually low level monetary, but social recognition, enhanced status, symbolic items also work.

Relapse Prevention

CBT based

Coping with cravings

Refusal and assertiveness skills

Analysis of how seemingly irrelevant

decisions can affect probability of use

event

Coping and problems solving skills

Strategies to prevent full relapse after a

8/9/2017

14

Matrix Model

Matrix of treatment modalities

Relapse prevention

Motivational Interviewing

Psychoeducation

Family/couples therapy

12 Step

Done in group sessions and 20 individual sessions over 24 weeks.

Thanks!

8/9/2017

15

NY State Psychiatric Institute Survey

August 9, 2017

Cooper, ZD; Adverse effects of synthetic cannabinoids: management

of acute toxicity and withdrawal; Curr Psychiatry Rep (2016) 18:52

29

• 3.5 yrs between April 2012-October 2015

• 1358 men/550 women


August 9, 2017



30

8/9/2017

16


August 9, 2017



31

Bath Salts in MichiganCase Report – MMWR, May 2011

• First report to summarize epidemiology of bath salt ED cases

• Based on 35 people who had ingested, inhaled, or injected

bath salts and subsequently visited a Michigan Emergency

Department (ED) between 11/13/10 and 3/31/11

• Patients presented with hypertension, tachycardia, tremors,

motor automatisms, mydriasis, delusions, and paranoia

• No relationship found between route of administration and

severity of illness


8/9/2017

17

Opioid Relapse rates following inpatient

treatment.

Relapse rates are v. high: (Pregnant Woman)

6 week program. N=109, 91% relapse, 59% within one week. Program completion delayed relapse by matter of weeks.

extended methadone inpatient detox (avg 15 days). N=73. 27% dropped out. Completers - 1 month, 65% back to using (14% still in residential). 6 months 63% using (9% still in residential).

1 year follow ups. Favor those who have been on medication assisted treatment over detox or residential.

Generally slow tapering with opioid substitution delays relapse and can encourage sustained opioid abstinence in a minority of patients.

Given a choice, most opt for substitution. Even pts who initially choose detox, opt for substitution once they experience withdrawal.

Review of Methadone

Fullerton CA, et al, Medication Assisted

Treatment with Methadone: Assessing the

Evidence, Psychiatric Services, Feb 2014,

Vol 65, no 2, 146-157

Review of meta-analyses, systematic

reviews, individual studies of MMT

between 1995-2012

24 trials, meta-analyses and large reviews

8/9/2017

18

Methadone Full agonist opioid, T ½ = ~22 hrs.

Active at CYP 3A4 and 2D6

Only available through licensed narcotic treatment programs for tx of dependence.

Has been tremendously marginalized as a treatment, but about 180,000 people nation wide are in treatment

When dosed correctly (between 60-120mg) and monitored closely, patients can do well

Good evidence methadone treatment increases participation in treatment programs, decreases heroin and other drug use, reduces HIV and viral hepatitis transmission, prevents early recidivism post release.

Main Findings

MMT v Placebo or no pharmacotherapy

Mostly published between the 1960s-90s.

By far more effective retaining pts in treatment

Improved suppression of heroin use

Reduced drug-related HIV and HCV risk behaviors

Better than brief and extended detoxification protocols, drug-free programs, wait-list controls

8/9/2017

19

Main Findings

Methadone dosing: Most studies classified dose ranges as Low (<40mg),

Moderate (40-60mg) and High (60-100mg). Literature generally supports higher dosing with

diminishing return at doses over 120mg/day Better tx retention, cocaine abstinence, less use of

heroin, less withdrawal at doses between 60-110mg. One well-designed double blind RTC (Strain et al, 1999)

comparing moderate dose (40-50mg) to high (80-100mg) showed no difference in tx retention, but sig better reduction in opioid positive urine in high dose group.

Medication Therapy All medications used for the treatment of

chemical addictions are best used as one part of a comprehensive psychosocial program of recovery.

All studies of medications for addiction demonstrate greater effectiveness when combined with behavioral therapy

Medications are not a substitute for a comprehensive recovery plan.

Policies and practices that forbid indefinite duration of treatment or deprive individuals access to housing, treatment and other resources when they are on opioid substitution are discriminatory.

8/9/2017

20

Main Findings Adverse Events:

390% increase in Methadone-related deaths between 1999-2004.

Mostly attributable to misguided opioid analgesia Highlighted toxicity risk, related to QT prolongation and

respiratory depression. Especially during the initiation phase.

Respiratory depression mainly a cumulative factor enhanced by co-administration of CNS depressants.

Generally QT >500ms is associated with increased risk Must be mindful of medications that prolong QT (esp

psychotropics).

Review of Buprenorphine

Thomas, CP., et al, Medication Assisted Treatment with Buprenorphine: Assessing the Evidence, Psychiatric Services, Feb 2014, Vol65, no 2, 158-170

Review of meta-analyses, systematic reviews, individual studies of BMT between 1995-2012

19 studies: 16 RTCs, 1 randomized x-over study, 1 self-report survey, retrospective descriptive study.

8/9/2017

21

Buprenorphine/naloxone High affinity mu partial agonist and kappa

antagonist. Some CYP 3A4 activity.

Trade name SuboxoneTM

Long-acting (T ½ ~35hrs), less euphorigenic, prevents withdrawal sickness, works for pain, can block full agonist opioids, sublingual

Requires DEA waiver to Rx for opioid dependence

Requires abstinence from full agonist before first dose.

Common SEs: N/V, sedation, edema, HA, constipation

Buprenorphine/naloxone Unfortunately is abusable…BUT good

evidence it can be very effective as a maintenance treatment.

Studies with 6, 12 month and 2-5 year outcomes show dramatic reductions in heroin use (80-90%), other drug use, and much higher retention in treatment

High cost:benefit ratio especially when criminal recidivism factored in.

The data are sometimes at odds with popular beliefs about maintenance treatment

Lavignasse, P, et al. Ann Med Interne, 2002: 153(suppl 3), 1S20-1S26; Kakko J, et al., Lancet,

2003, 361:662-668; Fiellin, DA, et al., Am J Addict, 2008; 17(2): 116-120.

8/9/2017

22

Main Findings

BMT v Placebo Studies published since 1995.

By far more effective retaining pts in treatment at all dose ranges.

Improved suppression of heroin use

Medium (7-15mg) and high doses (>16mg) generally associated with effects on tx retention and reduction in illicit use.

Most studies show no significant impact on reducing non-opioid drug use compared to placebo.

Buprenorphine implant showed good retention over 6 months (66% v 31%). Sig diff in negative urine (40% v 28%). Sig reduction in COWS and SOWS.

Main Findings

BMT v MMT: Dosing in the high to mod range is most significant

factor in outcome.

In general methadone at medium and high doses performed better on primary outcomes of retention and illicit opioid use compared to medium and high dose bupe

In one RCT high-dose bupe matched high-dose methadone and did better than low dose methadone.

Stepped care model: BMT v MMT groups. BMT pts who got to 32mg Bupe but not stable stepped to MMT. Of the BMT who did not require step to MMT, mean dose of bupe was 29.6mg. Mean dose of methadone was ~110mg. Good retention and opioid free UDS in both groups at 6 months (76% and 80%).

8/9/2017

23

Review of Naltrexone Krupitsky E, et al., Injectable extended-release

naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomisedtrial. Lancet 2011, Apr 30: 377(9776): 1506-13.

RCT, 13 sites, 250 subjects. Conducted in Russia. Post inpatient, at least 7 days opioid free. 380mg XR-NTX v Placebo. 12 bi-weekly counseling sessions. Measured confirmed abstinence between weeks 5-24.

No positive data on oral naltrexone

No good head to head comparisons with BMT or MMT

Naltrexone (oral and depo) Available for both alcohol and opioid dependence

Trade names ReviaTM and VivitrolTM

Irreversible blockade of opioid receptors (mu, kappa and some gamma)

T1/2: 4h, 13h(b-naltrexol).

50mg daily dose. 380mg monthly dose of depo form. Oral dosing for opioids can be flexible up to 150mg q3 days.

Primary SEs: HA, dizziness, fatigue, anhedonia uncommon

Contraindicated in liver failure and active hepatitis (LFTs >3 times normal).

8/9/2017

24

Naltrexone There is some risk of liver toxicity so liver

function must be monitored when starting 50mg daily dose for alcohol. 380mg monthly

dose of depo form. Overall response rates are in the 10-20% range

– seems to work better in men with strong family history of alcoholism

Primary SEs: HA, dizziness, fatigue, anhedoniauncommon

Contraindicated in liver failure and active hepatitis (LFTs >3 times normal).

Main Findings Outcomes:

Primary: Confirmed abstinence during weeks 5-24 by UDS and self report Median proportion abstinent weeks was 90% in XR-NTX

v 35.0% in placebo by UDS.

Secondary: Self report opioid free days: 99.2% XR-NTX v 60.4%

placebo. Mean change in craving: -10.1 XR-NTX v 0.7 in

placebo Retention: median retention 168 days XR-NTX v 96

days placebo Relapse during treatment: 1 in XR-NTX group v 17 in

placebo

8/9/2017

25

Main Findings

Adverse Events:

During trial and one year open-label extension

Low rate of discontinuation due to adverse events

21% had study drug related AE

Injection site reactions in 6.1%

Elevations in LFTs in 16.7%

No deaths, ODs, or severe AEs

Abstinence-Based Outcomes Physicians monitoring studies (PHP)

5 year retrospective review of 16 PHPs 78% long term abstinent within program “long-term random monitoring with swift consequences

for substance use and meaningful leverage to enforce abstinence and continued participation” is key.

Australian 1-year heroin outcomes (ATOS) Comparable rates of self reported past month

abstinence between methadone and residential rehab groups. 65% in MMT and 63% in RR

Median of 138 residential treatment days Higher percentage of overdoses, heroin use days and

daily injecting in RR group v MMT

Hawaii Opportunity Probation with Enforcement (H.O.P.E.) and South Dakota’s 24/7 Sobriety Project for Recidivist Driving Under the Influence. Both with high rates of adherence in lieu of re-

incarceration.

8/9/2017

26

Cheeseburger, Chips, no

Coke…Pepsi!

Meeting patients and payors where they

are:

Briefer stays for specific goals

Targeted readmission

Outpatient support

Risk management and monitoring

Going “off script”

Prepare for calls by patients and payors for broader array of services

“new drugs”: drug use trends in texas today•kratom –opioid-like effects •krokodil –cheap...

Documents