Investigation of Naltrexone for Pathological Gambling
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
Collaborator:
National Center for Responsible Gaming
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT01057862
First received: January 25, 2010
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
The investigators plan to investigate the safety, tolerability, and efficacy of the opioid antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be superior to placebo in reducing gambling urges and behavior, when combined with adjuvant non-pharmacological treatment as usual.
| Condition | Intervention | Phase |
|---|---|---|
|
Pathological Gambling |
Drug: Naltrexone Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-Blind Placebo-Controlled Investigation of Naltrexone for Pathological Gambling |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) [ Time Frame: Weekly/bi-weekly visits ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Weekly/bi-weekly visits ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Naltrexone |
Drug: Naltrexone
Targeted dosage of 50mg PO daily
Other Name: Naltrexone hydrochloride
|
| Placebo Comparator: Placebo |
Other: Placebo
Sugar pills daily PO
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men or women over age 18
- Current DSM-IV PG Diagnosis as determined by a score of ≥ 5A criteria and B criterion present on the SCI-PG and a score ≥ 5 on the SOGS
- Gambling behavior within 2 weeks prior to enrollment
- For women, stable use of a medically accepted form of contraception and negative results on urine pregnancy test at study onset
- Currently entering, enrolled, or interested in treatment for PG
Exclusion Criteria:
- Gambling that does not meet DSM-IV criteria for PG
- Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen
- Past or current acute hepatitis or liver failure
- History of renal impairment
- Current or recent (within one week) treatment with an opioid agonist/opioid analgesic or current opioid withdrawal
- Opiate agonist maintenance therapy (e.g. methadone)
- Known sensitivity to opioid antagonists
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- A need for medication with unfavorable interactions with naltrexone
- Clinically significant suicidality
- Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by SCID
- Clinically significant cognitive impairment
- Previous treatment with naltrexone or nalmefene
- Treatment with investigational medication or depot neuroleptics within 3 months
- Lack of proficiency in written and spoken English
- Unable to travel to study sites for appointments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057862
Locations
| United States, Connecticut | |
| Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs | |
| Middletown, Connecticut, United States, 06457 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06519 | |
| Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs | |
| New Haven, Connecticut, United States, 06519 | |
Sponsors and Collaborators
Yale University
National Center for Responsible Gaming
Investigators
| Principal Investigator: | Marc N Potenza, M.D., Ph.D. | Yale University |
More Information
Publications:
| Responsible Party: | Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University |
| ClinicalTrials.gov Identifier: | NCT01057862 History of Changes |
| Other Study ID Numbers: | 0901004667, NCRG CORE R09240 |
| Study First Received: | January 25, 2010 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Naltrexone Pathological Gambling Opioid Antagonist |
Additional relevant MeSH terms:
|
Gambling Impulse Control Disorders Mental Disorders Naltrexone Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013