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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00605241
First received: January 18, 2008
Last updated: November 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Substance Dependence
Smoking
Drug: GSK598809
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: through 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stroop test [ Time Frame: through 10 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GSK598809
Drug
Drug: GSK598809
Drug

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605241

Locations
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00605241     History of Changes
Other Study ID Numbers: DAN106593
Study First Received: January 18, 2008
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacodynamics,
pharmacokinetics,
tolerability,
Safety,
single dose,
placebo,
Nicotine reward
GSK598809

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014