Memantine and Naltrexone Treatment for Opioid Dependence (NAMHS-1)
This study has been completed.
Sponsor:
New York State Psychiatric Institute
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00125515
First received: July 28, 2005
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependence |
Drug: Memantine Drug: Naltrexone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of NMDA Antagonist for Opiate Dependence |
Resource links provided by NLM:
Drug Information available for:
Naltrexone
Naltrexone hydrochloride
Memantine
Memantine hydrochloride
U.S. FDA Resources
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Retention in Treatment [ Time Frame: Number of participants who complete 12 weeks of treatment ] [ Designated as safety issue: Yes ]The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
| Enrollment: | 81 |
| Study Start Date: | June 2005 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo plus oral naltrexone
|
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone
|
|
Active Comparator: Memantine 30 mg bid
Memantine 30 mg bid plus oral naltrexone
|
Drug: Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Other Name: Memantine
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone
|
|
Active Comparator: Memantine 15 mg bid
memantine 15 mg bid plus oral naltrexone
|
Drug: Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Other Name: Memantine
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125515
Locations
| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
| Principal Investigator: | Adam Bisaga, M.D. | Columbia University |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00125515 History of Changes |
| Other Study ID Numbers: | #4847/R01-15822, K23DA000429 |
| Study First Received: | July 28, 2005 |
| Results First Received: | December 18, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
Heroin Opiates naltrexone memantine |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Memantine Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 21, 2013