Drug Treatment for Pathologic Gambling Disorder

NCT00053677 | Completed Phase 3 Results

• 2 other identifiers: R21MH065920DSIR AT-AS
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

Conditions

Gambling

Keywords

Impulse Control Disorders

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)

  A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.

  18 weeks

Study Arms (2)

Naltrexone

PLACEBO COMPARATOR

17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Subjects who were assigned to placebo in the 17 week double-blind phase.

Drug: Placebo

Interventions

Naltrexone DRUG

For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.

Naltrexone

Placebo DRUG

For subjects who were randomly assigned to placebo.

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual IV criteria for Pathological Gambling Disorder
• Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale
• No psychiatric drug use for 2 weeks or more
• Score \>= 5 on The South Oaks Gambling Screen
• Hamilton Depression Rating Scale and Anxiety Rating score \< 26. An increase (up to 10 points) of the scores is allowed unless the subject shows the risks of suicide.
• Completion of complete blood count, urinalysis, liver and thyroid function tests, and pregnancy tests, with no evidence of significant lab abnormalities
• Reliable birth control in women of child-bearing potential

Sponsors & Collaborators

• University of Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota Medical School

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (6)

• Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21. doi: 10.1016/s0006-3223(01)01079-4.

  PMID: 11377409 BACKGROUND

• Kim SW. Opioid antagonists in the treatment of impulse-control disorders. J Clin Psychiatry. 1998 Apr;59(4):159-64.

  PMID: 9590665 BACKGROUND

• Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9. doi: 10.1097/00004850-200109000-00006.

  PMID: 11552772 BACKGROUND

• Grant JE, Kim SW. Demographic and clinical features of 131 adult pathological gamblers. J Clin Psychiatry. 2001 Dec;62(12):957-62. doi: 10.4088/jcp.v62n1207.

  PMID: 11780876 BACKGROUND

• Kim SW, Grant JE. Personality dimensions in pathological gambling disorder and obsessive-compulsive disorder. Psychiatry Res. 2001 Nov 30;104(3):205-12. doi: 10.1016/s0165-1781(01)00327-4.

  PMID: 11728609 BACKGROUND

• Kim SW, Grant JE. The psychopharmacology of pathological gambling. Semin Clin Neuropsychiatry. 2001 Jul;6(3):184-94. doi: 10.1053/scnp.2001.22924.

  PMID: 11447570 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Gambling; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Pathological gambling is a chronic disease that may require long-term therapy. Although this study is one of the longest medication trials for PG, the study did not assess treatment effects beyond the acute 18-week treatment period.

Results Point of Contact

• Title: Dr. Jon E. Grant
• Organization: University of Chicago

jongrant@uchicago.edu

773-834-1325

Study Officials

• Suck Won Kim, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2003
• First Posted: February 5, 2003
• Study Start: December 1, 2002
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 23, 2023
• Results First Posted: October 3, 2017

Record last verified: 2023-02

Locations

US (1)