Drug Treatment for Pathologic Gambling Disorder

The University of Chicago

Status and phase: Completed; Phase 3

Conditions: Gambling

Treatments: Drug: Placebo; Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00053677

R21MH065920 (U.S. NIH Grant/Contract)

DSIR AT-AS

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

83 participants in 2 patient groups, including a placebo group

Naltrexone

Placebo Comparator group

Description:

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.

Treatment:

Drug: Naltrexone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo