Investigation of Naltrexone for Pathological Gambling

Completed · Phase 2 · Has a placebo group

Conditions studied: Pathological Gambling

In brief

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.

Key facts

Study ID

NCT01057862

Run by

Yale University

People needed

9

Starts

2009-02-01

Expected to finish

2017-01-01

Last updated by the study team

2017-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs — Middletown, Connecticut, United States
• Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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