Does Guanfacine Attenuate Stress-Induced Drinking?

NCT02164422 | Completed Phase 2 Results DMC

• 2 other identifiers: 1308012557R01AA022285
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Alcohol; Drinkers; Guanfacine

Outcome Measures

Primary Outcomes (1)

• mL Per 15 Minutes

  mL per 15 minutes during 2-hour ad-lib drinking period

  2 hour self administration period during lab sessions held on days 22 and 25

Study Arms (3)

Guanfacine 3mg/day

EXPERIMENTAL

Guanfacine 3mg/day

Drug: Guanfacine 3mg/day

Guanfacine 1.5mg/day

EXPERIMENTAL

Guanfacine 1.5mg/day

Drug: Guanfacine 1.5mg/day

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Guanfacine 3mg/day DRUG

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.

Also known as: Tenex

Guanfacine 3mg/day

Guanfacine 1.5mg/day DRUG

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.

Also known as: Tenex

Guanfacine 1.5mg/day

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Subjects likely to exhibit clinically significant alcohol withdrawal during the study.
• Individuals who are seeking treatment for drinking

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Sherry McKee
• Organization: Yale School of Medicine

sherry.mckee@yale.edu

2037373529

Study Officials

• Sherry A McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2014
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 8, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-07

Locations

US (1)