NCT03035708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

January 26, 2017

Results QC Date

August 30, 2019

Last Update Submit

October 22, 2019

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Cue-elicited Craving

    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).

    Study Week 3

Secondary Outcomes (4)

  • Percent Heavy Drinking Days

    Weeks 3-6

  • The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6).

    Weeks 3-6

  • Cigarettes Smoked Per Week

    Weeks 3-6

  • Penn Alcohol Craving Scale

    Study Weeks 3, 4, 5, 6 (assessed weekly during this period)

Study Arms (2)

varenicline

EXPERIMENTAL

1 mg BID (2 capsules BID)

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

1 mg BID (2 capsules BID)

Drug: Placebo oral capsule

Interventions

VareniclineDRUG

1 mg BID

Also known as: Chantix
varenicline
Placebo oral capsuleDRUG

1 mg BID

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • oral contraceptives,
  • contraceptive sponge,
  • patch,
  • double barrier (diaphragm/spermicidal or condom/spermicidal),
  • intrauterine contraceptive system,
  • levonorgestrel implant,
  • medroxyprogesterone acetate contraceptive injection,
  • complete abstinence from sexual intercourse, and/or
  • hormonal vaginal contraceptive ring.
  • +6 more criteria

You may not qualify if:

  • Contact site for additional information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Health Scientist Administrator
Organization
National Institute on Alcohol Abuse and Alcoholism
falkde@mail.nih.gov
301-443-0788

Study Officials

  • Raye Litten, PhD

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

May 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 7, 2018

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)