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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK598809 | Other | Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK598809 | Drug | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Stroop test | through 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968817 | Background | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| DAN106593 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000594007 | GSK598809 |
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| Results for study DAN106593 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| DAN106593 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |