Phase 2
Completed N=70
Does Guanfacine Attenuate Stress-Induced Drinking?
Alcohol Drinking
Source: ClinicalTrials.gov NCT02164422 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: mL Per 15 Minutes — 85.850; 80.575; 114.104 mls of alcohol consumed per 15 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY mL Per 15 Minutes |
85.850; 80.575; 114.104 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02164422). 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. Informational only — not medical advice.