Overview

Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Memantine
Naltrexone
Criteria
Inclusion Criteria:

1. Adult, aged 18-60.

2. 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.

3. Able to give informed consent.

Exclusion Criteria:

1. Pregnancy, lactation, or failure in a sexually active woman to use adequate
contraceptive methods.

2. 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).

3. 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.

4. History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone,
clonidine, or clonazepam.

5. Currently prescribed or regularly taking opiates for chronic pain or medical illness.

6. Current participation in another intensive psychotherapy or substance abuse treatment
program or currently prescribed psychotropic medications.

7. Current participation in a methadone maintenance treatment program and/or regular use
of illicit methadone (>30 mg per week).

8. 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.