Phase 2 N=9 Randomized Quadruple-blind Treatment

Investigation of Naltrexone for Pathological Gambling

Pathological Gambling

Bottom Line

View on ClinicalTrials.gov: NCT01057862 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) — 16.0; 17.0; 10.0; 4.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naltrexone (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)	16.0; 17.0; 10.0; 4.0	—
SECONDARY Gambling Symptom Assessment Scale (G-SAS)	26.8; 24.75; 12.6; 1.0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01057862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.