Phase 2
N=56
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Alcohol Drinking
Bottom Line
View on ClinicalTrials.gov: NCT01519063 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Drinks Consumed at Lab Session (Day 7) — 4.11; 5.02 drinks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone and memantine first (Drug); Naltrexone and Placebo first (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinks Consumed at Lab Session (Day 7) |
4.11; 5.02 | — |
| PRIMARY Craving AUC: Adlib Drinking Phase |
7.62; 7.75 | — |
| PRIMARY Stimulation Response to Alcohol at Lab Session |
4.78; 4.93 | — |
| PRIMARY Sedation Response to Alcohol at Lab Session |
5.42; 5.34 | — |
| PRIMARY Craving AUC: Priming Dose Phase |
6.81; 6.84 | — |
| PRIMARY Sedation Response to Alcohol: Priming Dose Phase |
3.87; 3.76 | — |
| PRIMARY Stimulation Response to Alcohol: Priming Dose Phase |
3.20; 3.43 | — |
Summary
The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.
Eligibility Criteria
Inclusion Criteria
- Ages 21-55
- Able to read English at 6th grade level or higher and to complete study evaluations
- Regular alcohol drinker
Exclusion Criteria
- Individuals who are seeking alcohol treatment
- Medical conditions that would contraindicate the use of study medication
- Regular use of other substances
Data sourced from ClinicalTrials.gov (NCT01519063). 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.