Clinical trial NCT01052662: Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Official title: Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opioid Dependence
Keywords: Drug Abuse
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-01-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Opioid Use From Week 1 to 13
timeFrame: Weekly from week 1 to 13
measure: Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8
timeFrame: Weeks after buprenorphine discontinuation week 9
Secondary outcomes:
measure: Treatment Retention
timeFrame: Weekly
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Gerardo Gonzalez, M.D.
role: PRINCIPAL_INVESTIGATOR
References: