Investigation of Naltrexone for Pathological Gambling

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Center for Responsible Gaming
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

1. Men or women over age 18

2. 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

3. Gambling behavior within 2 weeks prior to enrollment

4. For women, stable use of a medically accepted form of contraception and negative results on urine pregnancy test at study onset

5. Currently entering, enrolled, or interested in treatment for PG

Exclusion Criteria:

1. Gambling that does not meet DSM-IV criteria for PG

2. Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen

3. Past or current acute hepatitis or liver failure

4. History of renal impairment

5. Current or recent (within one week) treatment with an opioid agonist/opioid analgesic or current opioid withdrawal

6. Opiate agonist maintenance therapy (e.g. methadone)

7. Known sensitivity to opioid antagonists

8. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

9. A need for medication with unfavorable interactions with naltrexone

10. Clinically significant suicidality

11. Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by SCID

12. Clinically significant cognitive impairment

13. Previous treatment with naltrexone or nalmefene

14. Treatment with investigational medication or depot neuroleptics within 3 months

15. Lack of proficiency in written and spoken English

16. Unable to travel to study sites for appointments