Dronabinol Naltrexone Treatment for Opioid Dependence

Condition(s) targeted: Opioid Dependence

Intervention: injectable naltrexone plus dronabinol (Drug); Naltrexone plus placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Adam Bisaga, MD, Principal Investigator, Affiliation: Columbia University

Overall contact:
Elizabeth Martinez, Phone: (212) 923-3031, Email: martine@pi.cpmc.columbia.edu

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Official title: Dronabinol Naltrexone Treatment for Opioid Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Opiate withdrawal and craving as measured by the SOWS and craving scales.

Secondary outcome: Retention

Detailed description: The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone + Placebo (N=20) and (2) Naltrexone + dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1. Adult, aged 18-60.

- 2. Meets DSM-IV criteria for current opiate dependence disorder of at least six

months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.

- 3. Have a history of marijuana use (more than 30 occasions lifetime)

- 4. Voluntarily seeking treatment for opioid dependence

- 5. In otherwise good health based on complete medical history, physical examination,

vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.

- 6. Able to give informed consent.

Exclusion Criteria:

- 1. Physiologically dependent on alcohol or sedative-hypnotics with impending

withdrawal.

- 2. Patients meeting current criteria for cannabis abuse or dependence, and those who

used cannabis in the week prior to study entry as documented by the positive toxicology

- 3. Current DSM-IV criteria of other substance use disorders. Exceptions include

cannabis abuse or dependence, nicotine dependence, cocaine abuse or dependence, alcohol abuse or alcohol dependence without physiological dependence as long as opioid dependence is a primary disorder. Alcohol dependence with physiological dependence is exclusionary.

- 4. Significant current suicidal risk or 1 or more suicide attempts within the past

year

- 5. History of accidental drug overdose in the last three years defined as an episode

of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.

- 6. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory

method of birth control

- 7. Active psychiatric disorder which might interfere with participation or make

participation hazardous, including DSM-IV organic mental disorder, psychotic disorder, or bipolar disorder with mania

- 8. History of allergic reaction, adverse reaction, or sensitivity to any study

medication.

- 9. Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal

range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)

- 10. Currently prescribed or regularly taking opiates for chronic pain or medical

illness.

- 11. Current participation in a methadone maintenance treatment program and/or regular

use of illicit methadone (>30 mg per week).

- 12. Current participation in another intensive psychotherapy or substance abuse

treatment program or participation in another treatment study.

- 13. Concurrent treatment with psychotropic medications

Elizabeth Martinez, Phone: (212) 923-3031, Email: martine@pi.cpmc.columbia.edu

New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Daniel Brooks, Email: brooksd@pi.cpmc.columbia.edu
Nabil Khan, Email: khannab@pi.cpmc.columbia.edu
Adam Bisaga, M.D., Principal Investigator

Starting date: January 2010
Last updated: October 25, 2012