Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

NCT00476242 | Completed Phase 2 Results

• 2 other identifiers: #5936R R01 DA015822-01R01DA015822
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.

Conditions

Opioid Dependence; Heroin Dependence

Keywords

heroin abuse; opiate abuse; opioid dependence; naltrexone; memantine

Outcome Measures

Primary Outcomes (2)

• Opiate Use Measured by Urine Toxicology Results

  Opiate use was qualified by the number of opiate positive urine results.

  3x/week during 12 weeks of the trial or study participation

• Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).

  Week 12

Secondary Outcomes (1)

• Opiate Craving Based on Heroin Craving Scale

  Average of twice weekly assessments for 12 weeks of study or length of participation

Study Arms (2)

Memantine and Vivitrol

EXPERIMENTAL

intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)

Drug: Vivitrol; Drug: memantine

Placebo and Vivitrol

PLACEBO COMPARATOR

intramuscular injection of Vivitrol 380 mg and Placebo

Drug: Vivitrol

Interventions

Vivitrol DRUG

intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)

Also known as: intramuscular injection of Vivitrol 380 mg

Memantine and Vivitrol; Placebo and Vivitrol

memantine DRUG

Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.

Memantine and Vivitrol

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 Diagnostic and Statistical Manual IV (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, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
• Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with serum glutamic oxaloacetic transaminase or serum glutamic-pyruvic transaminase levels \>2 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
• Active psychiatric disorder which 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 three 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)

STARS

New York, New York, 10032, United States

Location

Related Publications (1)

• Bisaga A, Sullivan MA, Cheng WY, Carpenter KM, Mariani JJ, Levin FR, Raby WN, Nunes EV. A placebo controlled trial of memantine as an adjunct to oral naltrexone for opioid dependence. Drug Alcohol Depend. 2011 Dec 1;119(1-2):e23-9. doi: 10.1016/j.drugalcdep.2011.05.019. Epub 2011 Jun 28.

  PMID: 21715107 RESULT

Related Links

• stars website

MeSH Terms

Conditions

Opioid-Related Disorders; Heroin Dependence

Interventions

vivitrol; Memantine

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

Results Point of Contact

• Title: Adam Bisaga
• Organization: NYS Psychiatric Institute

amb107@columbia.edu

646-774-6155

Study Officials

• Adam Bisaga, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: June 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 17, 2018
• Results First Posted: July 4, 2014

Record last verified: 2018-06

Locations

US (1)