Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
This study is currently recruiting participants.
Verified February 2013 by University of Massachusetts, Worcester
Sponsor:
University of Massachusetts, Worcester
Collaborator:
Information provided by (Responsible Party):
Gerardo Gonzalez, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01052662
First received: January 18, 2010
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependence |
Drug: Memantine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults |
Resource links provided by NLM:
Drug Information available for:
Memantine
Memantine hydrochloride
Buprenorphine
Buprenorphine hydrochloride
U.S. FDA Resources
Further study details as provided by University of Massachusetts, Worcester:
Primary Outcome Measures:
- Rates of medication emergent side effects as assessed by weekly questionnaire [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
- Change in illicit opioid use as measured by self-report drug use and confirmed by urine toxicology [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Early relapse rates as measured by self-report and urine toxicology after agonist discontinuation [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Memantine 30mg/day + Suboxone |
Drug: Memantine
30mg/day Memantine orally everyday for 12 weeks
|
| Experimental: Memantine 15mg/day + Suboxone |
Drug: Memantine
15 mg/day Memantine orally everyday for 12 weeks
|
| Placebo Comparator: Memantine 0mg/day + Suboxone |
Drug: Placebo
Placebo orally everyday for 12 weeks
|
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| Ages Eligible for Study: | 18 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052662
Contacts
| Contact: Ethan Cochran, B.A. | 508-856-4566 | suboxoneresearchstudy@umassmed.edu |
Locations
| United States, Massachusetts | |
| University of Massachusetts Medical School | Recruiting |
| Worcester, Massachusetts, United States, 01605 | |
| Principal Investigator: Gerardo Gonzalez, M.D. | |
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
| Principal Investigator: | Gerardo Gonzalez, M.D. | University of Massachusetts, Worcester |
More Information
No publications provided
| Responsible Party: | Gerardo Gonzalez, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01052662 History of Changes |
| Other Study ID Numbers: | H-13261, 1R01DA027138-01 |
| Study First Received: | January 18, 2010 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
Drug Abuse |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Memantine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 19, 2013