Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00695500
• Date of registration: 11/06/2008
• Prospective Registration: No
• Primary sponsor: Vijay Ramchandani, Ph.D.
• Public title: Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
• Scientific title: A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
• Date of first enrolment: June 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00695500
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Vijay A Ramchandani, Ph.D.
• Affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

- Age 21 to 60 years of age.

- In good health.

- Drink a weekly average of 15 and 20 standard alcoholic drinks (12 gm
ethanol/beverage), respectively, for women and men.

- Have a working phone number.

EXCLUSION CRITERIA:

- Currently seeking help for an alcohol problem.

- Subjects with clinically significant alcohol withdrawal.

- More than thirty days of abstinence from alcohol in the ninety days prior to
enrollment.

- A positive breath alcohol concentration (BrAC) at the first visit

- A history of major alcohol-related complications at any time, such as pancreatitis.

- Any serious cardiovascular condition or high risk factors, evidenced by any of the
following:

- Current or past diagnosis of coronary artery disease (such as ischemia, angina,
congestive heart failure, myocardial infarction) or peripheral arterial disease;

- Current or past diagnosis of diabetes, or casual glucose level > 200 mg/dl;

- Elevated blood pressure (above 160/100) at screening,

- Elevated lipid levels: LDL > 160 mg/dL, HDL < 40 mg/dL for males or < 45 mg/dL
for females;

- Clinically significant ECG abnormalities or unstable arrhythmias.

- Contraindication(s) to take the study medication as listed in the package insert.

- Contraindication(s) to take the study medication as listed in the package insert.

- Psychiatric problems requiring clinical attention: a current or past diagnosis of
major depression, panic disorder, eating disorders, post traumatic stress disorder,
schizophrenia, bipolar disorder, or obsessive compulsive disorder. Individuals who
report lifetime (past or current) history of suicidal ideation, suicide attempts or
self injury.

- Recent (within the last two months) or regular use of illicit or non-prescribed
psycho-active substances such as opiates, benzodiazepines, cocaine, PCP,
methamphetamines/other psychostimulants or marijuana.

- Psycho-social instability (e.g. no fixed address, no reliable secondary person to
contact in case of an emergency).

- Women who are lactating, are trying to become pregnant or who are not willing to
practice safe and effective birth control.

- Moderate-to-severe renal impairment defined as estimated or measured creatinine
clearance less than 30 mL/min.

- Use of bupropion or nicotine replacement therapy within 90 days of the protocol,
inhibitors/substrates for renal cationic transporters, or medications contraindicated
with ethanol.

- Exclusion criteria for MRI scanning, including metal in body (such as implants,
pacemaker, prostheses, shrapnel, irremovable piercing), left-handedness, and
claustrophobia.

- A history of violence or aggression, assessed as part of the clinical interview at
screening visit.



Age minimum: 21 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alcohol Drinking

Intervention(s)

Drug: Placebo

Drug: Varenicline

Primary Outcome(s)

Alcohol Consumption [Time Frame: 2.5 hr session following 3 weeks of treatment]

Secondary Outcome(s)

Alcohol Urges [Time Frame: 2.5 hr session following 3 weeks of treatment]

Secondary ID(s)

08-AA-0137

080137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Results

• Results available: Yes
• Date Posted: 15/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00695500