Drug Treatment for Pathologic Gambling Disorder

Gambling Clinical Trial

Official title:

Naltrexone Treatment in Pathologic Gambling Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053677
• Other study ID #: R21MH065920
• Secondary ID: R21MH065920DSIR
• Status: Completed
• Phase: Phase 3
• Start date: December 2002
• Est. completion date: November 2005

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism.

Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gambling

Intervention

Drug:
• Naltrexone
For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
• Placebo
For subjects who were randomly assigned to placebo.

Locations

Country	Name	City	State
United States	University of Minnesota Medical School	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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