Pathological GamblingPhase 4NCT01528007
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention
A Phase 4 study testing Naltrexone pharmacotherapy in people with Pathological Gambling, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled… 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?
- Naltrexone pharmacotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Sep 2013
- Phase
- Phase 4
- 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
- pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria)
Who cannot join
- acute hepatitis
- severe liver or kidney dysfunction
- suicide risk or severe depression or other untreated mental health problem
- participation to other gambling research at the same time
- the use of drugs (especially opiates)
- pregnancy
- prisoners
- retarded and mentally ill patients were also excluded
Trial locations and contacts
1 site in 1 country.
Finland1 site
National Institute for Health and Welfare
Helsinki, Uusimaa, 00530
About this study
Official title: Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled double-blind trial.
Read the detailed description
All participants have to be able to read and understand the patient information sheet and sign the informed consent. All participants are free to stop being in the study whenever they wanted. The patients are not paid or reimbursed for participation.
The study periods is 21 weeks during which the participant's have 8 appointments with the researchers. During the meetings research data will be collected and the participant is having Controlled Behavioral Therapy (CBT) consulting from a trained therapist. At the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). In this study the maximal daily dose is 50mg of naltrexone. The medication is free for the subjects.
- Conditions
- Pathological Gambling
- Being tested
- Naltrexone pharmacotherapy, Placebo
- Keywords
- Pathological gambling, Treatment intervention
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone pharmacotherapyDrug
Naltrexone 50mg when graving to gamble.
PlaceboDrug
Placebo pill with no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill. | Placebo comparator | Not described Receives: Drug: Placebo |
| 50mg Naltrexone when needed | Active comparator | Not described Receives: Drug: Naltrexone pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-YBOCS.
The investigators will interview PG-YBOCS questionnaire from the participants.
Measured: Up to 21 weeks.
Secondary outcomes (2)
Alcohol use.
The investigators will ask the participants to fill in AUDIT questionnaire.
Measured: Up to 21 weeks.
Quality of life.
The investigators will ask the participants to fill in RAND 36 questionnaire.
Measured: Up to 21 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hannu Alho, Finnish Institute for Health and Welfare
- Investigators
- Hannu Alho, Professor, Principal investigator, Finnish Institute for Health and WelfareTuuli Lahti, Adjunct Professor, Study director, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528007
- Sponsor's protocol ID
- 03062010
- Other IDs
- 2010-021123-26
- Status last verified
- Dec 2013
- First submitted
- 28 Oct 2011
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- 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 36130734Kovanen L, Basnet S, Castren S, Pankakoski M, Saarikoski ST, Partonen T, Alho H, Lahti T. A Randomised, Double-Blind, Placebo-Controlled Trial of As-Needed Naltrexone in the Treatment of Pathological Gambling. Eur Addict Res. 2016;22(2):70-9. doi: 10.1159/000435876. Epub 2015 Sep 5.
PubMed 26339899
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01528007
- Acronym / sponsor ID
- 03062010
- Conditions
- Pathological Gambling
- Keywords
- Pathological gambling, Treatment intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Feb 2012 (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.
The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled double-blind trial.
Detailed description
All participants have to be able to read and understand the patient information sheet and sign the informed consent. All participants are free to stop being in the study whenever they wanted. The patients are not paid or reimbursed for participation.
The study periods is 21 weeks during which the participant's have 8 appointments with the researchers. During the meetings research data will be collected and the participant is having Controlled Behavioral Therapy (CBT) consulting from a trained therapist. At the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). In this study the maximal daily dose is 50mg of naltrexone. The medication is free for the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill. | Placebo comparator | Drug: Placebo |
| 50mg Naltrexone when needed | Active comparator | Drug: Naltrexone pharmacotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria)
Key exclusion criteria (8 listed)
- acute hepatitis
- severe liver or kidney dysfunction
- suicide risk or severe depression or other untreated mental health problem
- participation to other gambling research at the same time
- the use of drugs (especially opiates)
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 |
|---|---|---|
| Naltrexone pharmacotherapyNaltrexone 50mg when graving to gamble. | Drug | 50mg Naltrexone when needed |
| PlaceboPlacebo pill with no active ingredients. | Drug | Placebo pill. |
Primary outcome
PG-YBOCS.
Time frame: Up to 21 weeks.
The investigators will interview PG-YBOCS questionnaire from the participants.
2 secondary outcomes
Alcohol use.
Time frame: Up to 21 weeks.
Quality of life.
Time frame: Up to 21 weeks.
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 5 Dec 2013.
- 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.
- Derived from this study: PubMed 26339899Kovanen L, Basnet S, Castren S, Pankakoski M, Saarikoski ST, Partonen T, Alho H, Lahti T. A Randomised, Double-Blind, Placebo-Controlled Trial of As-Needed Naltrexone in the Treatment of Pathological Gambling. Eur Addict Res. 2016;22(2):70-9. doi: 10.1159/000435876. Epub 2015 Sep 5.
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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.
Hannu Alho, Professor principal investigator
Finnish Institute for Health and Welfare
Tuuli Lahti, Adjunct Professor study director
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone pharmacotherapy in people with Pathological Gambling, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 1 inclusion and 8 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 5 Dec 2013. 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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.
What does the primary outcome measure?
PG-YBOCS. (time frame: Up to 21 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 NCT01528007, which also lists 2 linked publications.
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 5 Dec 2013.