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

Substance Dependence Clinical Trial

Official title:

A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605241
• Other study ID #: DAN106593
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2008
• Last updated: July 19, 2017
• Start date: February 25, 2008
• Est. completion date: March 20, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 20, 2009
• Est. primary completion date: March 20, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• GSK598809
Drug

Locations

Country	Name	City	State
United States	GSK Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		through 24 hours
Secondary	Stroop test		through 10 hours

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study DAN106593 can be found on the GSK Clinical Study Register.