Memantine and Naltrexone Treatment for Opioid Dependence

Opioid Dependence Clinical Trial

— NAMHS-1  

Official title:

Evaluation of NMDA Antagonist for Opiate Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125515
• Other study ID #: #4847/R01-15822
• Secondary ID: K23DA000429
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: August 2008

Study information

• Verified date: May 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
• Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   stars website