This trial is active, not recruiting.

Condition opioid dependence
Treatments memantine, placebo
Phase phase 3
Sponsor University of Massachusetts, Worcester
Collaborator National Institute on Drug Abuse (NIDA)
Start date October 2009
End date June 2013
Trial size 90 participants
Trial identifier NCT01052662, 1R01DA027138-01, H-13261


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
30mg/day Memantine orally everyday for 12 weeks
15 mg/day Memantine orally everyday for 12 weeks
(Placebo Comparator)
Placebo orally everyday for 12 weeks

Primary Outcomes

Rates of medication emergent side effects as assessed by weekly questionnaire
time frame: Weekly
Change in illicit opioid use as measured by self-report drug use and confirmed by urine toxicology
time frame: Weekly
Early relapse rates as measured by self-report and urine toxicology after agonist discontinuation
time frame: End of treatment

Secondary Outcomes

Secondary outcomes will include weeks in treatment (retention), VAS opioid craving, change in measures of control over impulsive behavior, and anxiety symptoms.
time frame: Weekly

Eligibility Criteria

Male or female participants from 18 years up to 25 years old.

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

Additional Information

Official title Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Principal investigator Gerardo Gonzalez, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of Massachusetts, Worcester.