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Human Laboratory Study of Varenicline for Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03035708
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study designed to assess the effects of varenicline as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Varenicline Drug: Placebo oral capsule Phase 1 Phase 2

Detailed Description:

This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study designed to assess the effects of varenicline as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting. After signing informed consent, subjects will be screened for eligibility including medical history, physical examination, vital signs, electrocardiogram (ECG), drinking history by the timeline follow-back (TLFB) method, alcohol breathalyzer test, Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA), medication use, MINI neuropsychiatric interview, urine toxicology screen, clinical chemistry, response to cue reactivity, and Columbia Suicide Severity Rating Scale (CSSR-S). Women of child-bearting potential will have a pregnancy test. If eligible for the study, subjects will be randomized using a stratified permuted block randomization procedure in an approximate 1:1 ratio (targeting 24 subjects per group - 12 subjects per group per site) to receive either varenicline or placebo for 6 weeks. Any nicotine use versus no use (cigarettes, cigars, chewing tobacco, electronic cigarettes, etc.) in the week before randomization is the stratification variable.

Varenicline or matched placebo will be titrated over the first week of the study up the maintenance dose of 1 mg (active) or two capsules (placebo) taken orally BID for an additional 5 weeks. Subjects will be seen in the clinic at screening, at randomization and 6 other times during the study. A final follow-up telephone interview will occur during Week 9 (2 weeks after the end of study visit).

After the first two weeks and after five weeks of investigational product administration at Study Week 3 and Study Week 6, respectively, subjects will undergo a cue reactivity paradigm session (HLAB) including 4 individual visual analog scale (VAS) items assessing alcohol craving, 2 VAS items assessing emotional reactivity to picture stimuli, and 2 items assessing emotional manipulation. Immediately after the HLAB session, subjects will view each picture again and record the emotion felt using the Self-Manikin Assessment (SAM). Other assessments at baseline (prior to the first dose of investigational product) and/or during the maintenance period include clinical chemistry, mood/behavior/thinking questions, blood for medication compliance, vital signs, ECG, concomitant medications, CIWA-AR, pregnancy test and birth control methods, drinking goal, adverse events (AEs), Alcohol Craving Questionnaire - Short Form (ACQ-SF-R), Penn Alcohol Craving Scale (PACS), Fagerström Test for Nicotine Dependence, smoking quantity/frequency, Pittsburg Sleep Quality Index (PSQI), and Profile Of Moods State (POMS).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Human Laboratory Study of Varenicline for Alcohol Use Disorder
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: varenicline
1 mg BID (2 capsules BID)
Drug: Varenicline
1 mg BID
Other Name: Chantix

Placebo Comparator: Placebo
1 mg BID (2 capsules BID)
Drug: Placebo oral capsule
1 mg BID




Primary Outcome Measures :
  1. Cue-elicited craving [ Time Frame: Study Week 3 ]
    The primary objective of this study is to evaluate the effect of varenicline 1 mg twice-daily (BID), compared with matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after two weeks of BID daily dosing among subjects with moderate alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible, the subject must:

  • Be at least 21 years of age.
  • Meet the DSM 5 criteria for alcohol use disorder of a least moderate severity (AUD-MS).
  • Be seeking treatment for AUD and desire a reduction or cessation of drinking.
  • Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
  • Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:

    1. oral contraceptives,
    2. contraceptive sponge,
    3. patch,
    4. double barrier (diaphragm/spermicidal or condom/spermicidal),
    5. intrauterine contraceptive system,
    6. levonorgestrel implant,
    7. medroxyprogesterone acetate contraceptive injection,
    8. complete abstinence from sexual intercourse, and/or
    9. hormonal vaginal contraceptive ring.
  • Be able to take oral medication and be willing to adhere to the medication regimen.
  • Complete all assessments required at screening and baseline.
  • Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months.
  • Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
  • Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
  • And others.

Exclusion Criteria:

  • Contact site for additional information

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): NCT03035708


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Study Director: Raye Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT03035708     History of Changes
Other Study ID Numbers: HLAB 001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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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Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs