Memantine and Naltrexone Treatment for Opioid Dependence

NCT00125515 | Completed Phase 2 Results DMC

• 2 other identifiers: #4847/R01-15822K23DA000429
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Dependence

Keywords

Heroin; Opiates; naltrexone; memantine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo plus oral naltrexone

Drug: Naltrexone

Memantine 30 mg bid

ACTIVE COMPARATOR

Memantine 30 mg bid plus oral naltrexone

Drug: Memantine; Drug: Naltrexone

Memantine 15 mg bid

ACTIVE COMPARATOR

memantine 15 mg bid plus oral naltrexone

Drug: Memantine; Drug: Naltrexone

Interventions

Memantine DRUG

One arm receives 30 mg bid and the other arm receives receives 15mg bid

Memantine 15 mg bid; Memantine 30 mg bid

Naltrexone DRUG

Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

Memantine 15 mg bid; Memantine 30 mg bid; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• stars website

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Memantine; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

It is possible that concomitant naltrexone might have exacerbated protracted withdrawal, thus masking the potential ameliorative effects of memantine that have been previously observed in other trials.

Results Point of Contact

• Title: Dr Adam Bisaga
• Organization: New York Psychiatric Institute

bisagaa@nyspi.columbia.edu

212-543-6542

Study Officials

• Adam Bisaga, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: July 28, 2005
• First Posted: August 1, 2005
• Study Start: June 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 18, 2018
• Results First Posted: January 24, 2013

Record last verified: 2018-05

Locations

US (1)