Pathological GamblingNCT00055393
Bupropion in the Treatment of Pathological Gambling
A study testing Bupropion in people with Pathological Gambling, run by University of Iowa at 1 site in United States.
Trial summary
This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Bupropion Versus Placebo in the Treatment of Pathological Gambling
This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.
Read the 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.
- Conditions
- Pathological Gambling
- Being tested
- Bupropion, Placebo
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
18 subjects in this randomly controlled double blind study received bupropion.
PlaceboDrug
21 subjects received Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receivng Bupropion | Active comparator | The active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial. Receives: Drug: Bupropion |
| Subjects receiving Placebo | Placebo comparator | The inactive arm subjects in this randomly controlled study (n = 21) received a placebo. Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2003 (estimated)
- Study startJul 2002
- Primary completionMay 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Donald Black, University of Iowa
- Investigators
- Donald W Black, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055393
- Sponsor's protocol ID
- 200007038
- Other IDs
- R21MH063289, DSIR AT-AS
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2003
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Black DW, Arndt S, Coryell WH, Argo T, Forbush KT, Shaw MC, Perry P, Allen J. Bupropion in the treatment of pathological gambling: a randomized, double-blind, placebo-controlled, flexible-dose study. J Clin Psychopharmacol. 2007 Apr;27(2):143-50. doi: 10.1097/01.jcp.0000264985.25109.25.
PubMed 17414236
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion Versus Placebo in the Treatment of Pathological Gambling
- ClinicalTrials.gov ID
- NCT00055393
- Acronym / sponsor ID
- 200007038
- Conditions
- Pathological Gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2002
- Primary completion
- May 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 3 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether the drug bupropion is an effective treatment for Pathological Gambling.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receivng Bupropion | Active comparator | Drug: BupropionThe active arm subjects in this study (n = 18) received flexibly dosed bupropion in this randomized 12-week double-blind trial. |
| Subjects receiving Placebo | Placebo comparator | Drug: PlaceboThe inactive arm subjects in this randomly controlled study (n = 21) received a placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion18 subjects in this randomly controlled double blind study received bupropion. | Drug | Subjects receivng Bupropion |
| Placebo21 subjects received Placebo. | Drug | Subjects receiving Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Results publication: PubMed 17414236Black DW, Arndt S, Coryell WH, Argo T, Forbush KT, Shaw MC, Perry P, Allen J. Bupropion in the treatment of pathological gambling: a randomized, double-blind, placebo-controlled, flexible-dose study. J Clin Psychopharmacol. 2007 Apr;27(2):143-50. doi: 10.1097/01.jcp.0000264985.25109.25.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald W Black, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion in people with Pathological Gambling, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00055393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.