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Varenicline for Alcohol Dependence (NCIG 003)

Primary Purpose

Alcoholism

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Varenicline

Placebo

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol, Alcohol abuse, Alcoholism, Alcohol Dependence, Varenicline, Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be at least 18 years of age.
Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
Be seeking treatment for alcohol dependence 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,
9. hormonal vaginal contraceptive ring, and/or
Be able to take oral medication and be willing to adhere to the medication regimen
Complete all assessments required at screening and baseline.
Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study.
Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
Be someone who in the opinion of the investigator would be expected to complete the study protocol.
Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.

Sites / Locations

Johns Hopkins University School of Medicine
Boston Medical Center
Dartmouth Medical School
Dartmouth Medical School
University of Pennsylvania
University of Virginia
University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline

Sugar Pill

Arm Description

Varenicline Tartrate

Outcomes

Primary Outcome Measures

Weekly Percentage of Heavy Drinking Days

Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.

Secondary Outcome Measures

Full Information

NCT ID

NCT01146613

First Posted

June 16, 2010

Last Updated

August 20, 2014

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT01146613

Brief Title

Varenicline for Alcohol Dependence

Acronym

NCIG 003

Official Title

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary

The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

Keywords

Alcohol, Alcohol abuse, Alcoholism, Alcohol Dependence, Varenicline, Drinking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varenicline

Arm Type

Active Comparator

Arm Description

Varenicline Tartrate

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Chantix

Intervention Description

0.5mg capsules x 2, 2x a day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

identical matched placebo x 2, 2xday, 13 weeks

Primary Outcome Measure Information:

Title

Weekly Percentage of Heavy Drinking Days

Description

Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.

Time Frame

Weeks 2-13*

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be at least 18 years of age. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence. Be seeking treatment for alcohol dependence 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, hormonal vaginal contraceptive ring, and/or Be able to take oral medication and be willing to adhere to the medication regimen Complete all assessments required at screening and baseline. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document. Be someone who in the opinion of the investigator would be expected to complete the study protocol. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raye Z. Litten, PhD

Organizational Affiliation

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Joanne Fertig, PhD

Organizational Affiliation

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel E Falk, PhD

Organizational Affiliation

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Dartmouth Medical School

City

Bedford

State/Province

New Hampshire

ZIP/Postal Code

03110

Country

United States

Facility Name

Dartmouth Medical School

City

Hanover

State/Province

New Hampshire

ZIP/Postal Code

03755

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

University of Virginia

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30865232

Citation

Falk DE, O'Malley SS, Witkiewitz K, Anton RF, Litten RZ, Slater M, Kranzler HR, Mann KF, Hasin DS, Johnson B, Meulien D, Ryan M, Fertig J; Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Psychiatry. 2019 Apr 1;76(4):374-381. doi: 10.1001/jamapsychiatry.2018.3079.

Results Reference

derived

PubMed Identifier

26083958

Citation

Falk DE, Castle IJ, Ryan M, Fertig J, Litten RZ. Moderators of Varenicline Treatment Effects in a Double-Blind, Placebo-Controlled Trial for Alcohol Dependence: An Exploratory Analysis. J Addict Med. 2015 Jul-Aug;9(4):296-303. doi: 10.1097/ADM.0000000000000133.

Results Reference

derived

PubMed Identifier

23728065

Citation

Litten RZ, Ryan ML, Fertig JB, Falk DE, Johnson B, Dunn KE, Green AI, Pettinati HM, Ciraulo DA, Sarid-Segal O, Kampman K, Brunette MF, Strain EC, Tiouririne NA, Ransom J, Scott C, Stout R; NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. J Addict Med. 2013 Jul-Aug;7(4):277-86. doi: 10.1097/ADM.0b013e31829623f4.

Results Reference

derived

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Varenicline for Alcohol Dependence

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