Memantine and Naltrexone Treatment for Opioid Dependence

Study Overview
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Brief Summary
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The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

Detailed Description
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The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone. This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Official Title
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Evaluation of NMDA Antagonist for Opiate Dependence

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: Memantine
* Drug: Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion: Adult, aged 18-60. 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. Able to give informed consent. Exclusion: Pregnancy or breastfeeding Failure in a sexually active woman to use adequate contraceptive methods Active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels > 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia) Active psychiatric disorder that might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year. History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam Currently prescribed or regularly taking opiates for chronic pain or medical illness Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone ( > 30 mg per week) History of accidental drug overdose in the last 3 years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo plus oral naltrexone | Drug: Naltrexone<br>* Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.<br>|
| Active Comparator: Memantine 30 mg bid<br>Memantine 30 mg bid plus oral naltrexone | Drug: Memantine<br>* One arm receives 30 mg bid and the other arm receives receives 15mg bid<br>Drug: Naltrexone<br>* Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.<br>|
| Active Comparator: Memantine 15 mg bid<br>memantine 15 mg bid plus oral naltrexone | Drug: Memantine<br>* One arm receives 30 mg bid and the other arm receives receives 15mg bid<br>Drug: Naltrexone<br>* Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in Treatment | The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups. | Number of participants who complete 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heroin, Opiates, naltrexone, memantine