Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00125515
Other study ID # #4847/R01-15822
Secondary ID K23DA000429
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2005
Est. completion date August 2008

Study information

Verified date May 2018
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02294253 - Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone Phase 2/Phase 3
Completed NCT01592461 - Starting Treatment With Agonist Replacement Therapies Follow-up Study N/A
Terminated NCT00768482 - A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence Phase 3
Completed NCT01741350 - Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users N/A
Terminated NCT04121546 - Collaborative Care for Opioid Dependence And Pain Pilot Study N/A
Withdrawn NCT03368794 - Naloxone to TReatment Entry in the Emergency Setting N/A
Completed NCT03447743 - Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder Early Phase 1
Completed NCT04464421 - SMART Effectiveness Trial N/A
Recruiting NCT04189523 - Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Recruiting NCT04003948 - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification Phase 2
Not yet recruiting NCT03813095 - Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction Phase 2
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT01895270 - Improving Buprenorphine Detoxification Outcomes With Isradipine Phase 1/Phase 2
Completed NCT01717963 - Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway Phase 3
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1

External Links