Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Opioid Dependence, Heroin Dependence

In brief

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.

Key facts

Study ID

NCT00476242

Run by

New York State Psychiatric Institute

People needed

82

Starts

2008-06-01

Expected to finish

2011-08-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• STARS — New York, New York, United States

Full record on ClinicalTrials.gov

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