Bupropion in the Treatment of Pathological Gambling

Study Overview
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Brief Summary
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This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.

Detailed Description
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As gambling opportunities proliferate, PG has become a major health concern. Despite its importance, few treatment options with proven efficacy exist. This study will attempt to identify an effective treatment for PG. Participants are randomly assigned to receive either bupropion or placebo for 12 weeks. Participants are assessed at baseline and at Weeks 2, 3, 4, 5, 6, 8, 10, and 12. Self administered questionnaires and interviews are used to assess participants. Follow-up assessments are made 1, 3, and 6 months after study completion.

Official Title
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Bupropion Versus Placebo in the Treatment of Pathological Gambling

Conditions
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Pathological Gambling

Intervention / Treatment
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* Drug: Bupropion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the criteria for Pathological Gambling (DSM-IV-TR), through the administration of the National Opinion Research Center DSM Screen for Gambling Problems(NODS); Meet the criteria for Pathological Gambling (DSM-IV-TR), through the administration of the National Opinion Research Center DSM Screen for Gambling Problems(NODS); Receive a score of 5 or more on the South Oaks Gambling Screen (SOGS); Have PG for at least one year; Have had at least 2 or more gambling episodes during the 2-week screening period; Speak standard English; Be able to give written informed consent. Exclusion Criteria: Evidence of current (past 3 months) substance misuse; Had a Hamilton Depression Rating Scale (HDRS)27 score of 18 or more (or a score on item 1 of greater than 2; Had a current eating disorder (except binge eating disorder); Had any history of seizures, or suicidal or aggressive behavior; Had a urine drug screen positive for stimulants, opiates, hallucinogens, or phencyclidine; Had a current or past psychotic disorder, bipolar disorder, or significant cognitive disorder; Received monoamine oxidase inhibitors within 3 weeks of randomization, long acting phenothiazine within 3 months of randomization,fluoxetine within 4 weeks of randomization, or other psychotropic drugs within 2 weeks of randomization; Had prior exposure to bupropion; Were engaged in individual, group, or couples psychotherapy during the 2 weeks before randomization, (except Gamblers Anonymous).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects receivng Bupropion<br>The active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial. | Drug: Bupropion<br>* 18 subjects in this randomly controlled double blind study received bupropion.<br>|
| Placebo Comparator: Subjects receiving Placebo<br>The inactive arm subjects in this randomly controlled study (n = 21) received a placebo. | Drug: Placebo<br>* 21 subjects received Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |