Alcohol Abuse
Conditions
Brief summary
This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.
Detailed description
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.
Interventions
DRUGPuerarin, Placebo
400 mg, three times a day for 7 days
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* moderate to heavy alcohol drinkers (20+ drinks per week)
Exclusion criteria
* alcohol dependence or treatment-seeking drinkers * other drug abuse or dependence * psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of Alcohol Consumed | During a 90 minute drinking session |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo, Then Puerarin | 8 |
| Puerarin, Then Placebo | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 1 | 1 |
| Second Intervention | Physician Decision | 0 | 1 |
| Second Intervention | Protocol Violation | 1 | 0 |
| Washout | Protocol Violation | 1 | 0 |
| Washout | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Puerarin, Then Placebo | Placebo, Then Puerarin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age Continuous | 24.5 years STANDARD_DEVIATION 3.7 | 24.3 years STANDARD_DEVIATION 2.9 | 24.4 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Amount of Alcohol Consumed
Time frame: During a 90 minute drinking session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Puerarin | Amount of Alcohol Consumed | 3.46 Number of drinks consumed | Standard Error 0.55 |
| Puerarin, Then Placebo | Amount of Alcohol Consumed | 2.36 Number of drinks consumed | Standard Error 0.41 |