Bupropion in the Treatment of Pathological Gambling

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald Black, University of Iowa
ClinicalTrials.gov Identifier:
NCT00055393
First received: February 28, 2003
Last updated: May 14, 2016
Last verified: May 2016
  Purpose
This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.

Condition Intervention
Pathological Gambling
Drug: Bupropion
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bupropion Versus Placebo in the Treatment of Pathological Gambling

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Enrollment: 80
Study Start Date: July 2002
Study Completion Date: April 2006
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subjects receivng Bupropion
The active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial.
Drug: Bupropion
18 subjects in this randomly controlled double blind study received bupropion.
Placebo Comparator: Subjects receiving Placebo
The inactive arm subjects in this randomly controlled study (n = 21) received a placebo.
Drug: Placebo
21 subjects received Placebo.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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); 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).

  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: NCT00055393

Locations
United States, Iowa
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Donald W Black, MD University of Iowa
  More Information

Responsible Party: Donald Black, Professor of and MD in Psychiatry, University of Iowa
ClinicalTrials.gov Identifier: NCT00055393     History of Changes
Other Study ID Numbers: IRB 200007038  R21MH063289  DSIR AT-AS 
Study First Received: February 28, 2003
Last Updated: May 14, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 27, 2016