Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

University of Massachusetts, Worcester87 enrolled

Overview

The purpose of this study is to examine the effect of memantine and buprenorphine on opioid abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and to evaluate the tolerability of memantine co-administrated with buprenorphine. The study seeks to determine if combined treatment of memantine and buprenorphine may provide shorter-term treatment for opioid dependence.

Opiate dependence is an increasing problem among young adults (18-25 years old) whose rates of current use of illicit drugs are generally high (19.7 %)according to data from the 2007 National Survey on Drug Use \& Health (Substance Abuse and Mental Health Services Administration 2008). Young adults start using heroin around this age range, and more recently have had increasing rates of prescription-type drug use. Given that young adults with opiate dependence who are seeking treatment are relatively treatment naïve, have a shorter period of addiction, and are more likely to choose buprenorphine over methadone, developing short-term buprenorphine treatment alternatives to long-term methadone agonist treatment is needed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Opioid Dependence

Interventions

MemantineDRUG

30mg/day Memantine orally everyday for 12 weeks

MemantineDRUG

15 mg/day Memantine orally everyday for 12 weeks

PlaceboDRUG

Placebo orally everyday for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women between 18-25 years old * Opioid dependence as evidenced by signs of opiate withdrawal, self-reported history of opioid dependence for a consecutive 12 month period and positive urine for opioids Exclusion Criteria: * Current diagnosis of other drug or alcohol dependence (other than opiates, cannabis or tobacco) * Serious medical illness (e.g. major cardiovascular, renal, endocrine, hepatic disorder) * Current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder and participants with suicidal or homicidal thoughts * Women who are pregnant, nursing or refuse to use a reliable form of birth control or refuse monthly pregnancy testing * Screening liver function tests (SGOT or SGPT) greater than 3 times normal

Locations (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Change of Opioid Use From Week 1 to 13

The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.

Time frame: Weekly from week 1 to 13

Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8

Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.

Time frame: Weeks after buprenorphine discontinuation week 9

Secondary Outcomes

Treatment Retention

Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.

Time frame: Weekly

Data from ClinicalTrials.gov

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