---
title: Varenicline for Alcohol Dependence
nct_id: NCT01146613
overall_status: COMPLETED
phase: PHASE2
sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
study_type: INTERVENTIONAL
primary_condition: Alcoholism
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01146613.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01146613"
ct_last_update_post_date: 2014-08-27
last_seen_at: "2026-05-12T06:55:03.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Varenicline for Alcohol Dependence

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

**NCT ID:** [NCT01146613](https://clinicaltrials.gov/study/NCT01146613)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- **Conditions:** Alcoholism
- **Start Date:** 2011-02
- **Completion Date:** 2012-07
- **CT.gov Last Update:** 2014-08-27

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Be at least 18 years of age.
2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.
4. 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.
5. 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
6. Be able to take oral medication and be willing to adhere to the medication regimen
7. Complete all assessments required at screening and baseline.
8. 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.
9. 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.
10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
11. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
12. 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.
```

## Arms

- **Varenicline** (ACTIVE_COMPARATOR) — Varenicline Tartrate
- **Sugar Pill** (PLACEBO_COMPARATOR)

## Interventions

- **Varenicline** (DRUG) — 0.5mg capsules x 2, 2x a day for 12 weeks
- **Placebo** (DRUG) — identical matched placebo x 2, 2xday, 13 weeks

## Primary Outcomes

- **Weekly Percentage of Heavy Drinking Days** _(time frame: Weeks 2-13*)_ — 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.

## Locations (7)

- Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
- Boston Medical Center, Boston, Massachusetts, United States
- Dartmouth Medical School, Bedford, New Hampshire, United States
- Dartmouth Medical School, Hanover, New Hampshire, United States
- University of Pennsylvania, Philadelphia, Pennsylvania, United States
- University of Virginia, Charlottesville, Virginia, United States
- University of Virginia, Richmond, Virginia, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.johns hopkins university school of medicine|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.boston medical center|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.dartmouth medical school|bedford|new hampshire|united states` — added _(2026-05-12)_
- `locations.dartmouth medical school|hanover|new hampshire|united states` — added _(2026-05-12)_
- `locations.university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.university of virginia|charlottesville|virginia|united states` — added _(2026-05-12)_
- `locations.university of virginia|richmond|virginia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01146613.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01146613*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*