Effectiveness of GSK598809, a Selective D3 Antagonist, Added to Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation and Prevention of Very Early Relapse to Smoking

Nicotine Dependence Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Parallel Group Design Trial of the Selective D3 Antagonist, GSK598809, Added to Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation and Prevention of Very Early Relapse to Smoking

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01188967
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	August 2010
Completion date	May 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05176418` - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate	Early Phase 1
Completed	`NCT04084210` - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use	Phase 2
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Withdrawn	`NCT03707600` - State and Trait Mediated Response to TMS in Substance Use Disorder	N/A
Recruiting	`NCT03999099` - Targeting Orexin to Treat Nicotine Dependence	Phase 1
Completed	`NCT03847155` - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery	N/A
Completed	`NCT02840435` - Study on Sit to Quit Phone Intervention	N/A
Completed	`NCT02139930` - Project 2: Strategies for Reducing Nicotine Content in Cigarettes	N/A
Completed	`NCT01926626` - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers	Phase 2
Completed	`NCT01982110` - A Mindfulness Based Application for Smoking Cessation	N/A
Withdrawn	`NCT01569477` - Striving to Quit-Wisconsin Tobacco Quit Line	N/A
Completed	`NCT01685996` - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation	Phase 1/Phase 2
Completed	`NCT01569490` - Striving to Quit: First Breath	N/A
Completed	`NCT01632189` - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT00996034` - Nicotine Vaccination and Nicotinic Receptor Occupancy	Phase 2
Completed	`NCT01061528` - Coping Skills Treatment for Smoking Cessation	N/A
Withdrawn	`NCT01589081` - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect	N/A
Completed	`NCT01943994` - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study	N/A
Suspended	`NCT01636336` - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.