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Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?

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ClinicalTrials.gov Identifier: NCT03588754
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief Summary:
For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: Propranolol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Propranolol
Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state.
Drug: Propranolol
Propranolol Extended Release (160mg/day).

Placebo Comparator: Placebo
Administered orally once daily at 10:00PM
Drug: Placebo
Placebo pill administered orally.




Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 120 minutes ]
    Mean mls of alcohol consumed (maximum of 120 mg/dL) for propranolol and placebo groups during 120 minute alcohol self administration sessions taking place as close to Day 15 and Day 19 as possible of medication dosing.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 21-65
  2. Able to read and write English
  3. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current (past 6 months) alcohol use disorders
  4. Able to take oral medications and willing to adhere to medication regimen

Exclusion Criteria:

  1. Participants with any significant current medical conditions.
  2. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)
  3. Suicidal, homicidal or evidence of current (past 6-month) mental illness.
  4. Specific exclusions for administration of propranolol not already specified.
  5. Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588754


Contacts
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Contact: Sabrina Coppola 203-737-2827 sabrina.coppola@yale.edu
Contact: Paula Cunningham 203-785-3547 paula.cunningham@yale.edu

Locations
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United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Sabrina Coppola    203-737-2827    sabrina.coppola@yale.edu   
Contact: Paula Cunningham    203-785-3547    paula.cunningham@yale.edu   
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Sherry McKee, PhD Professor

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Responsible Party: Sherry McKee, Professor, Yale University
ClinicalTrials.gov Identifier: NCT03588754     History of Changes
Other Study ID Numbers: 2000022090
R01AA022285 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Propranolol
Alcohol Drinking
Drinking Behavior
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents