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The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALC and NAL | Experimental | alcohol and active naltrexone |
|
| Sham ALC and NAL | Active Comparator | "sham" alcohol and active naltrexone |
|
| placebo pill and ALC | Placebo Comparator | placebo naltrexone and alcohol |
|
| placebo pill and Sham ALC | Placebo Comparator | placebo naltrexone and placebo (non-alcoholic) alcohol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | 50 mg/day for two days prior to the alcohol challenge session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biphasic Alcohol Effects Scale - Stimulation | Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome. | During challenge sessions |
| Profile of Mood States - Vigor | Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome | during the challenge session |
| Subjective High From Alcohol Scale | Change from baseline to peak for the self reported feeling of being high after drinking Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes | during the alcohol ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Biphasic Alcohol Effects Scale - Sedation | Change from baseline to peak of the amount of sedation post ingestion of alcohol Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes | During the challenge session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Oslin, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Treatment Research Center | Philadelphia | Pennsylvania | 19104 | United States |
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Participants were only randomized to 4 sequences and not to all 12 possible sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ntx-Alc; Placebo-Sham; Ntx-Sham; Placebo-Alc | Session1: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session2:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session3: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session4: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. |
| FG001 | Ntx-Sham; Ntx-Alc; Placebo-Alc; Placebo-Sham | Session1: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session2: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session3: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session4: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol |
| FG002 | Placebo-Alc; Ntx-Sham; Placebo-Sham; Ntx-Alc | Session1: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session2: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session3:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session4: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. |
| FG003 | Placebo-Sham; Placebo-Alc; Ntx-Alc; Ntx-Sham | Session1: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session2: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session3: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. Session4: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session1 |
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| Session2 |
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| Session3 |
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| Session4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | all participants in the cross over study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biphasic Alcohol Effects Scale - Stimulation | Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome. | Posted | Mean | Standard Deviation | units on a scale | During challenge sessions |
|
Adverse events were monitored during each session which typically occurred over 3 hours.
We assessed for any adverse event reported related to the medication taken prior to the session or the alcohol during the session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALC and NAL | alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oslin, MD | University of Pennsylvania | 2158235894 | oslin@upenn.edu |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D000431 | Ethanol |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| placebo | Drug | placebo pills |
|
| alcohol | Other | 190 proof alcohol prepared to 11% volume mixed with fruit juice. |
|
| Sham alcohol | Other | non-alcoholic placebo alcohol |
|
| Profile of Mood States - Fatigue Scale |
Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome |
| During the challenge session |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Alcohol use | The average number of standard drinks per week prior to the trial. | Mean | Standard Deviation | total number of drinks in the week prior |
|
| OG002 | Placebo Pill and ALC | placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. |
| OG003 | Placebo Pill and Placebo ALC | placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol |
|
|
| Primary | Profile of Mood States - Vigor | Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome | Posted | Mean | Standard Deviation | units on a scale | during the challenge session |
|
|
|
| Primary | Subjective High From Alcohol Scale | Change from baseline to peak for the self reported feeling of being high after drinking Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes | Posted | Mean | Standard Deviation | units on a scale | during the alcohol ingestion |
|
|
|
| Secondary | Biphasic Alcohol Effects Scale - Sedation | Change from baseline to peak of the amount of sedation post ingestion of alcohol Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes | Posted | Mean | Standard Deviation | units on a scale | During the challenge session |
|
|
|
| Secondary | Profile of Mood States - Fatigue Scale | Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome | Posted | Mean | Standard Deviation | units on a scale | During the challenge session |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo ALC and NAL | "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | Placebo Pill and ALC | placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG003 | Placebo Pill and Placebo ALC | placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol | 0 | 38 | 0 | 38 | 0 | 38 |
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |