AlcoholismPhase 2NCT00249431
Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
A Phase 2 study testing Sertraline and Relapse Prevention Therapy in people with Alcoholism and Gambling, run by New York State Psychiatric Institute.
Trial summary
Pathological gamblers often are also dependent on alcohol and clinically depressed. Sertraline (Zoloft) is currently used to treat depression, panic disorder, and obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism, Gambling
- What is being tested?
- Sertraline and Relapse Prevention Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Dec 2005
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for pathological gambling
- Meets DSM-IV and SCID criteria for alcohol abuse or dependence
- Medically healthy
Who cannot join
- History of schizophrenia, schizoaffective disorder, or bipolar disorder
- 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
Show all 13Show fewer
- 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
About this study
Official title: A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
Pathological gamblers often are also dependent on alcohol and clinically depressed. Sertraline (Zoloft) is currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline used in combination with relapse prevention therapy in decreasing gambling behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and alcohol abuse or dependence.
Read the detailed description
Alcohol abuse and depression commonly occur in conjunction with pathological gambling. Sertraline (Zoloft) is a selective serotonin reuptake inhibitor (SSRI) currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline combined with relapse prevention therapy in decreasing gambling behavior and alcohol abuse.
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
- Alcoholism, Gambling
- Being tested
- Sertraline, Relapse Prevention Therapy
- Keywords
- Gambling, Alcohol
- Medical subject headings
- Alcoholism, Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called zoloft
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 TherapyBehavioural
Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Relapse Prevention | Placebo comparator | Patients will be treated with Relapse Prevention Therapy plus placebo Receives: Behavioral: Relapse Prevention Therapy |
| Sertraline and Relapse Prevention | Active comparator | Patients will be treated with Relapse Prevention Therapy plus Sertraline. Receives: Drug: Sertraline; Behavioral: Relapse Prevention Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startDec 2001
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: Inability to recruit patients.
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 AlcoholismStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carlos Blanco, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249431
- Sponsor's protocol ID
- #5156R
- Other IDs
- 5K23DA000482
- Status last verified
- Oct 2017
- First submitted
- 3 Nov 2005
- Last updated
- 27 Oct 2017
- Results posted
- No
Publications
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.
PubMed 36130734
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Sertraline Plus Relapse Prevention Therapy (RP) for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
- ClinicalTrials.gov ID
- NCT00249431
- Acronym / sponsor ID
- #5156R
- Conditions
- Alcoholism, Gambling
- Keywords
- Gambling, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2001 (actual)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 7 Nov 2005 (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.
Pathological gamblers often are also dependent on alcohol and clinically depressed. Sertraline (Zoloft) is currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline used in combination with relapse prevention therapy in decreasing gambling behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and alcohol abuse or dependence.
Detailed description
Alcohol abuse and depression commonly occur in conjunction with pathological gambling. Sertraline (Zoloft) is a selective serotonin reuptake inhibitor (SSRI) currently used to treat depression, panic disorder, and obsessive-compulsive disorder. The purpose of this trial is to determine the effectiveness of sertraline combined with relapse prevention therapy in decreasing gambling behavior and alcohol abuse.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo and Relapse Prevention | Placebo comparator | Behavioral: Relapse Prevention TherapyPatients will be treated with Relapse Prevention Therapy plus placebo |
| Sertraline and Relapse Prevention | Active comparator | Drug: Sertraline, Behavioral: Relapse Prevention TherapyPatients will be treated with Relapse Prevention Therapy plus Sertraline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for pathological gambling
- Meets DSM-IV and SCID criteria for alcohol abuse or dependence
- Medically healthy
Key exclusion criteria (13 listed)
- History of schizophrenia, schizoaffective disorder, or bipolar disorder
- 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
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 |
|---|---|---|
| SertralineAlso: zoloftPatients 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 | Drug | Sertraline and Relapse Prevention |
| Relapse Prevention TherapyPatients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires. | Behavioural | Placebo and Relapse Prevention, Sertraline and Relapse Prevention |
Primary outcome
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
Time frame: 10 weeks
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale.
Results and safety
The study was stopped early (reason given: Inability to recruit patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 36130734Dowling 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.
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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.
Carlos Blanco, M.D. principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline and Relapse Prevention Therapy in people with Alcoholism and Gambling, run by New York State Psychiatric Institute.
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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit patients.). Results are not available in the source record.
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.
What does the primary outcome measure?
Decreased gambling behavior; measured throughout study by the Clinical Global Impression Scale. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249431, 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 27 Oct 2017.