Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
NCT ID: NCT00249431
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2001-12-31
2005-12-31
Brief Summary
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Detailed Description
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Participants in this 10-week trial will be randomly assigned to receive either relapse prevention (RP) therapy and sertraline or RP therapy and a placebo. Participants will begin taking 25 mg of either sertraline or placebo in a single morning dose for one week. If, after one week, participants do not show improvement, the dose will increase to 50 mg per day during Week 2, and will increase by 50 mg per day every week thereafter to a maximal dose of 200 mg per day.
Weekly hour-long study visits will include a medication evaluation, RP therapy, and questionnaires. In addition, evaluations at baseline, Week 5, and Week 10 will include pathological gambling and depression ratings, urine drug screens, and biochemical measures of alcohol consumption and liver function. All other weekly study visits will include evaluation of side effects, an interview on alcohol use, measures related to obsessive-compulsive drinking, and assessments of vital signs and concomitant medications.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo and Relapse Prevention
Patients will be treated with Relapse Prevention Therapy plus placebo
Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
Sertraline and Relapse Prevention
Patients will be treated with Relapse Prevention Therapy plus Sertraline.
Sertraline
Patients will be started on 25mg/day of Sertraline, and their dose will be increased to 50 mg/day by week two, and then weekly by 50mg/day based on clinical response and emergence of side effects. The maximum dose will be 200mg/day
Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
Interventions
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Sertraline
Patients will be started on 25mg/day of Sertraline, and their dose will be increased to 50 mg/day by week two, and then weekly by 50mg/day based on clinical response and emergence of side effects. The maximum dose will be 200mg/day
Relapse Prevention Therapy
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets DSM-IV and SCID criteria for alcohol abuse or dependence
* Medically healthy
Exclusion Criteria
* Current diagnosis of substance abuse or dependence, other than alcohol or nicotine
* Current major depression
* Currently suicidal
* History of non-response to an adequate trial of sertraline, defined as 200 mg per day of sertraline for at least a 4-week period
* Previous treatment with relapse prevention therapy for pathological gambling or alcohol dependence within the 3 months prior to study entry
* Requires treatment with psychotropic medication
* Unwilling to consent to a drug-free period, according to the following: 2 weeks of abstinence from antidepressant drugs, other than fluoxetine, buspirone, lithium, anticonvulsants, barbiturates, opiates, or benzodiazepines; 4 weeks of abstinence from clonazepam; 5 weeks of abstinence from fluoxetine
* Clinically significant disorder, including kidney, pulmonary, cerebral vascular, cardiovascular, gastrointestinal, and endocrine disorders
* Abnormal laboratory tests
* Abnormal electrocardiogram
* Pregnant or breastfeeding
* Unwilling to use an adequate method of contraception for the duration of the study
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Carlos Blanco, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Countries
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References
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Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Other Identifiers
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#5156R
Identifier Type: -
Identifier Source: org_study_id