Drug Treatment for Pathologic Gambling Disorder

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00053677
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gambling	Drug: Naltrexone; Drug: Placebo	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Naltrexone Treatment in Pathologic Gambling Disorder
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Naltrexone 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; For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
Placebo Comparator: Placebo Subjects who were assigned to placebo in the 17 week double-blind phase.	Drug: Placebo; For subjects who were randomly assigned to placebo.

Outcome Measures

Primary Outcome Measures

1. Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) [18 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Medical School	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Chicago
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Suck Won Kim, M.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Grant JE, Kim SW. Demographic and clinical features of 131 adult pathological gamblers. J Clin Psychiatry. 2001 Dec;62(12):957-62.
• 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.
• Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9.
• Kim SW, Grant JE. Personality dimensions in pathological gambling disorder and obsessive-compulsive disorder. Psychiatry Res. 2001 Nov 30;104(3):205-12.
• Kim SW, Grant JE. The psychopharmacology of pathological gambling. Semin Clin Neuropsychiatry. 2001 Jul;6(3):184-94. Review.
• Kim SW. Opioid antagonists in the treatment of impulse-control disorders. J Clin Psychiatry. 1998 Apr;59(4):159-64.

• Responsible Party: Jon Grant, Professor, University of Chicago
• ClinicalTrials.gov Identifier: NCT00053677
• Other Study ID Numbers: R21MH065920; R21MH065920; DSIR AT-AS
• First Posted: Feb 5, 2003
• Last Update Posted: Oct 3, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Jon Grant, Professor, University of Chicago: Impulse Control Disorders
• Additional relevant MeSH terms: Gambling; Naltrexone

Study Results

Participant Flow

Pre-assignment Detail	83 participants began the placebo lead-in phase. 6 of those were placebo responders. The remaining 77 were randomized to Naltrexone or placebo.

Arm/Group Title	Naltrexone	Placebo
Arm/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. Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.	Subjects who were assigned to placebo in the 17 week double-blind phase. Placebo: For subjects who were randomly assigned to placebo.
Period Title: Overall Study
STARTED	58	19
COMPLETED	36	13
NOT COMPLETED	22	6

Baseline Characteristics

Arm/Group Title	Naltrexone	Placebo	Total
Arm/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. Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.	Subjects who were assigned to placebo in the 17 week double-blind phase. Placebo: For subjects who were randomly assigned to placebo.	Total of all reporting groups
Overall Participants	58	19	77
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.8 (9.65)	44.7 (9.67)	46.3 (9.66)
Sex: Female, Male (Count of Participants)
Female	37 63.8%	10 52.6%	47 61%
Male	21 36.2%	9 47.4%	30 39%
Race/Ethnicity, Customized (Count of Participants)
White	54 93.1%	16 84.2%	70 90.9%
Other Race	4 6.9%	3 15.8%	7 9.1%
Region of Enrollment (participants) [Number]
United States	58 100%	19 100%	77 100%

Outcome Measures

1. Primary Outcome

Title	Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)
Description	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.
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone	Placebo
Arm/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. Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.	Subjects who were assigned to placebo in the 17 week double-blind phase. Placebo: For subjects who were randomly assigned to placebo.
Measure Participants	58	19
Baseline	16.9 (6.60)	18.6 (4.90)
Final Visit Score	9.7 (8.12)	12.9 (9.31)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the study (18 weeks per subject).
Arm/Group Title	Naltrexone		Placebo
Arm/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. Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.		Subjects who were assigned to placebo in the 17 week double-blind phase. Placebo: For subjects who were randomly assigned to placebo.
All Cause Mortality
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/58 (86.2%)		17/19 (89.5%)
Gastrointestinal disorders
Nausea	35/58 (60.3%)		7/19 (36.8%)
Diarrhea	8/58 (13.8%)		6/19 (31.6%)
Constipation	3/58 (5.2%)		3/19 (15.8%)
General disorders
Dry Mouth	8/58 (13.8%)		2/19 (10.5%)
Dizziness	6/58 (10.3%)		1/19 (5.3%)
Nervous system disorders
Headache	23/58 (39.7%)		9/19 (47.4%)
Insomnia	7/58 (12.1%)		0/19 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.