Effectiveness of Varenicline: Testing Individual Differences

The Mind Research Network

Status and phase: Completed; Phase 4

Conditions: Smoking Addiction

Treatments: Drug: Placebo; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01228175

R01DA025074 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.

Enrollment: 218 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 yrs to 55 yrs
• smoker

Exclusion criteria

• Medical Contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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218 participants in 2 patient groups, including a placebo group

Varenicline

Active Comparator group

Description:

Varenicline

Treatment:

Drug: Varenicline

Microcrystal Cellulose

Placebo Comparator group

Description:

Microcrystal cellulose placebo

Treatment:

Drug: Placebo