Dronabinol Naltrexone Treatment for Opioid Dependence

Official Title: “Dronabinol Naltrexone Treatment for Opioid Dependence”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: injectable naltrexone plus dronabinol
  • Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
• Drug: Naltrexone plus placebo
  • Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Naltrexone plus placebo
  • A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
• Experimental: Naltrexone plus dronabinol
  • A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.

Primary Measures

• Opiate withdrawal and craving as measured by the SOWS and craving scales.
  • Time Frame: 3x/week during 8 weeks of the trial or study participation
    Safety Issue?: No

Secondary Measures

• Retention
  • Time Frame: retention over 8 weeks.
    Safety Issue?: No

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 the3. Current DSM-IV criteria of other substance use disorders, (and excepting nicotine dependence).
• 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. Uncontrolled neurological, cardiovascular, renal, and hepatic diseases, active tuberculosis, AIDS, or any other disorder that might make administration of study medications hazardous 10. 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) 11. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
• 12. Current participation in another intensive psychotherapy or substance abuse treatment program, or participation in another treatment study.
• 13. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
• 14. Concurrent treatment with psychotropic medications

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: New York State Psychiatric Institute Other

Overall Clinical Trial Officials and Contacts

Adam Bisaga, MD Principal Investigator Columbia University  

Overall Contact: Elizabeth Martinez (212) 923-3031 martine@pi.cpmc.columbia.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024335

Study ID Number: DA027124

ClinicalTrials.gov Identifier: NCT01024335

Health Authority: United States: Food and Drug Administration