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Completed

NCT Number: NCT00605241

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

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.

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Key information

Conditions

Substance Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK598809

Drug

Drug

Primary outcomes

  1. Pharmacokinetics

    Time frame: through 24 hours

Secondary outcomes

  1. Stroop test

    Time frame: through 10 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2008
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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