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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
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Results First Submitted Date  ICMJE August 30, 2019
Results First Posted Date  ICMJE October 23, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
Cue-elicited Craving [ Time Frame: Study Week 3 ]
The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
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™).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • Percent Heavy Drinking Days [ Time Frame: Weeks 3-6 ]
    The percentage of heavy drinking days during the last month of treatment (weeks 3-6). A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males.
  • The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6). [ Time Frame: Weeks 3-6 ]
    The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6).
  • Cigarettes Smoked Per Week [ Time Frame: Weeks 3-6 ]
    The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11). Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis.
  • Penn Alcohol Craving Scale [ Time Frame: Study Weeks 3, 4, 5, 6 (assessed weekly during this period) ]
    Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30. The measure was assessed at Study Weeks 3, 4, 5, and 6. The reported outcome is the adjusted mean total score across weeks 3-6.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Laboratory Study of Varenicline for Alcohol Use Disorder
Official Title  ICMJE Human Laboratory Study of Varenicline for Alcohol Use Disorder
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Drug: Varenicline
    1 mg BID
    Other Name: Chantix
  • Drug: Placebo oral capsule
    1 mg BID
Study Arms  ICMJE
  • Experimental: varenicline
    1 mg BID (2 capsules BID)
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    1 mg BID (2 capsules BID)
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
48
Actual Study Completion Date  ICMJE July 7, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035708
Other Study ID Numbers  ICMJE HLAB 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Raye Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP