Conditions: Nicotine Dependence
Keywords: Drugs, Investigational Nicotine Dependence Therapies for Relapse to Nicotine Relapse Prevention Smoking Cessation Nicotine Cessation Therapies
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.

Detailed description:
We propose to conduct a first test of the effect of the dopamine D3 receptor antagonist, GSK598809, on smoking behavior when treatment is started immediately following the quit date. To do this, we propose to conduct a 10-week, double-blind, placebo-controlled, proof of mechanism study in 90 adult smokers. Participants will complete baseline evaluations. They will receive manualized cognitive behavioral therapy, beginning prior to the quit date, and will set a quit date for the day before their week 2 study visit. They will be given short acting NRT (gum or lozenge) to use on their quit date. They will be asked to arrive for the week 2 visit with 18-24 hours abstinence and an expired air CO ≤ 10ppm. Those who do so will be randomly assigned to receive double blind GSK598809 or identical placebo for six weeks. Participants will begin double blind GSK598809 or placebo, both in conjunction with prn NRT up to 8 mg per day for two weeks. Participants will then continue double blind GSK598809 or placebo in the absence of NRT for 4 more weeks. At the end of this period (week 8 of the study), participants will then be followed 2 weeks after discontinuation of double blind treatment to complete the 10 weeks of the study.

Arms:
arm 1: Active medication arm 2: Placebo

Interventions: intervention 1: GSK598809 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose of 60 mg/day for a treatment period six weeks intervention 2: Placebo

Protocol document: