Phase 3
Completed N=87
Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Source: ClinicalTrials.gov NCT01052662 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Change of Opioid Use From Week 1 to 13 — 0.00; 0.27; 0.39 Mean Proportion of Opioid Use in Week 13 — p==0.00874
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Opioid Use From Week 1 to 13 |
0.00; 0.27; 0.39 | =0.00874 sig |
| PRIMARY Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8 |
5; 1; 8 | 1.2 |
| SECONDARY Treatment Retention |
9.3; 9; 9.7 | 0.64 |
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
Data sourced from ClinicalTrials.gov (NCT01052662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.