A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-25

Study Completion Date

2009-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention

NCT01188967

Nicotine Dependence

COMPLETED PHASE2

A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

NCT00728052

Substance Dependence

COMPLETED PHASE1

A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809

NCT00437840

Substance Dependence

COMPLETED PHASE1

Relapse Prevention Study in Newly Abstinent Smokers

NCT00793468

Substance Dependence

WITHDRAWN PHASE2

Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

NCT00218218

Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GSK598809

Drug

Group Type OTHER

GSK598809

Intervention Type DRUG

Drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK598809

Drug

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male smokers aged 18-65 with a desire to quit smoking.
* Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
* Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.

Exclusion Criteria

* Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
* History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
* History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
* History of cardiac or pulmonary disease/abnormalities.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Mugnaini M, Iavarone L, Cavallini P, Griffante C, Oliosi B, Savoia C, Beaver J, Rabiner EA, Micheli F, Heidbreder C, Andorn A, Merlo Pich E, Bani M. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013 Jan;38(2):302-12. doi: 10.1038/npp.2012.171. Epub 2012 Sep 12.

Reference Type BACKGROUND

PMID: 22968817 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.