A Phase 2 interventional study of Naltrexone and memantine first and Naltrexone and Placebo first in Alcohol Drinking, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Yale University · Phase 2, Interventional, and Other
The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.
Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 75 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Treatment with Naltrexone and memantine first
Drug: Naltrexone and memantine first · Drug: Naltrexone and Placebo first
Treatment with naltrexone and placebo first
Drug: Naltrexone and memantine first · Drug: Naltrexone and Placebo first
Naltrexone 50mg memantine 20mg
Also known as: memantine's brand name is Namenda, naltrexone's brand name is Revia
Naltrexone 50 mg Placebo
Also known as: naltrexone's brand name is Revia
Number of Drinks Consumed at Lab Session (Day 7)
Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.
Time frame: Day 7
Craving AUC: Adlib Drinking Phase
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.
Time frame: 50-230 minutes after the priming drink during lab session
Stimulation Response to Alcohol at Lab Session
Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.
Time frame: 50-230 minutes after the priming drink during lab session
Sedation Response to Alcohol at Lab Session
Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES. As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.
Time frame: 50-230 minutes after the priming drink during lab session
Craving AUC: Priming Dose Phase
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.
Time frame: 0-50 minutes after the priming drink
Sedation Response to Alcohol: Priming Dose Phase
Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
Time frame: 0-50 minutes after priming drink
Stimulation Response to Alcohol: Priming Dose Phase
Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
Time frame: 0-50 minutes after priming drink
| Milestone | Naltrexone and Memantine First | Naltrexone and Placebo First |
|---|---|---|
| Started | 26 | 30 |
| Completed | 19 | 25 |
| Not completed | 7 | 5 |
Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.
| drinks | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Number of Drinks Consumed at Lab Session (Day 7) | 4.11 ± 4.19 | 5.02 ± 4.32 |
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.
| log (units on a scale * minutes) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Craving AUC: Adlib Drinking Phase | 7.62 ± .54 | 7.75 ± .55 |
Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.
| log (units on a scale *minutes) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Stimulation Response to Alcohol at Lab Session | 4.78 ± 3.51 | 4.93 ± 3.45 |
Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES. As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.
| log (units on a scale *minutes) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Sedation Response to Alcohol at Lab Session | 5.42 ± 2.97 | 5.34 ± 3.08 |
Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.
| log (units on a scale *minutes) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Craving AUC: Priming Dose Phase | 6.81 ± .55 | 6.84 ± .57 |
Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
| log (units on a scale) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Sedation Response to Alcohol: Priming Dose Phase | 3.87 ± 2.49 | 3.76 ± 2.34 |
Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.
| log (units on a scale) | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| Stimulation Response to Alcohol: Priming Dose Phase | 3.20 ± 2.84 | 3.43 ± 2.71 |
Collected over Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naltrexone and Memantine | 0/47 (0%) | 0/47 (0%) | 3/47 (6.4%) |
| Naltrexone and Placebo | 0/46 (0%) | 0/46 (0%) | 3/46 (6.5%) |
| Event | Naltrexone and Memantine | Naltrexone and Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 3/47 | 3/46 |
| Age, Continuous(years) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Mean | 34 ± 8.5 | 33 ± 9.3 | 33 ± 8.9 |
| Sex: Female, Male(Participants) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 15 | 18 | 33 |
| Race/Ethnicity, Customized(Participants) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Caucasian | 16 | 20 | 36 |
| Non-Caucasian | 10 | 10 | 20 |
| Total number of drinks over past 90 days(drinks) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Mean | 166 ± 63 | 165 ± 1 | 165 ± 72 |
| Drinks per drinking day in past 90 days(drinks) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Mean | 7.2 ± 2.5 | 7.2 ± 2.9 | 7.2 ± 2.7 |
| Percent of drinking days over past 90 days(percent of days) | Naltrexone and Memantine First | Naltrexone and Placebo First | Total |
|---|---|---|---|
| Mean | 78 ± 16 | 75 ± 17 | 76 ± 16 |
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