Last updated: 11/04/2018 06:08:42
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetics
Timeframe: through 24 hours
Secondary outcomes:
Stroop test
Timeframe: through 10 hours
Interventions:
Drug: GSK598809
Enrollment:
29
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mugnaini Manolo, Laura Iavarone, Palmina Cavallini, Cristiana Griffante, Beatrice Oliosi, Chiara Savoia, Ilan Rabiner, John Beaver, Caryn Lerman, Christopher Jepson, Andrew Strasser, Fabrizio Micheli, Christian Heidbreder, Anne Andorn, Emilio Merlo Pich. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach . [Neuropsychopharmacology]. 2012;1-11.
Mugnaini Manolo, Laura Iavarone, Palmina Cavallini, Cristiana Griffante, Beatrice Oliosi, Chiara Savoia, Ilan Rabiner, John Beaver, Caryn Lerman, Christopher Jepson, Andrew Strasser, Fabrizio Micheli, Christian Heidbreder, Anne Andorn, Emilio Merlo Pich. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013;38(2):302-312
Medical condition
Substance Dependence
Product
GSK598809
Collaborators
Not applicable
Study date(s)
February 2008 to March 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-20-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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