Alcohol Drinking
Conditions
Keywords
Alcohol, Drinkers, Guanfacine
Brief summary
Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.
Interventions
DRUGGuanfacine 3mg/day
3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
DRUGGuanfacine 1.5mg/day
1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
DRUGPlacebo
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-65 * Able to read and write English * Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for current (past 6 months) alcohol abuse or alcohol dependence
Exclusion criteria
* Participants with any significant current medical conditions, seizures, delirium or hallucinations, or other unstable medical conditions including HIV * Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol dependence, or nicotine dependence * Women who are pregnant or nursing * Suicidal, homicidal or evidence of current (past 6-month) mental illness * Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD) * Specific exclusions for administration of guanfacine not already specified include: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3x normal or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines) * Subjects likely to exhibit clinically significant alcohol withdrawal during the study. * Individuals who are seeking treatment for drinking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mL Per 15 Minutes | 2 hour self administration period during lab sessions held on days 22 and 25 | mL per 15 minutes during 2-hour ad-lib drinking period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Guanfacine 3mg/Day Guanfacine 3mg/day
Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. | 24 |
| Guanfacine 1.5mg/Day Guanfacine 1.5mg/day
Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. | 20 |
| Placebo Placebo
Placebo | 23 |
| Total | 67 |
Baseline characteristics
| Characteristic | Placebo | Total | Guanfacine 3mg/Day | Guanfacine 1.5mg/Day |
|---|---|---|---|---|
| Age, Continuous | 37.04 years STANDARD_DEVIATION 13.482 | 34.60 years STANDARD_DEVIATION 12.754 | 37.21 years STANDARD_DEVIATION 12.504 | 28.65 years STANDARD_DEVIATION 10.594 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 35 Participants | 13 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 31 Participants | 11 Participants | 9 Participants |
| Region of Enrollment United States | 23 participants | 67 participants | 24 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 20 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 47 Participants | 19 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 3 / 25 | 2 / 22 | 3 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 | 0 / 23 |
Outcome results
Primary
mL Per 15 Minutes
mL per 15 minutes during 2-hour ad-lib drinking period
Time frame: 2 hour self administration period during lab sessions held on days 22 and 25
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine 3mg/Day | mL Per 15 Minutes | 85.850 mls of alcohol consumed per 15 minutes | Standard Error 5.217 |
| Guanfacine 1.5mg/Day | mL Per 15 Minutes | 80.575 mls of alcohol consumed per 15 minutes | Standard Error 5.567 |
| Placebo | mL Per 15 Minutes | 114.104 mls of alcohol consumed per 15 minutes | Standard Error 5.268 |