Double-Blind Naltrexone in Kleptomania

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00332579
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

Condition or Disease	Intervention/Treatment	Phase
Kleptomania	Drug: Naltrexone; Drug: Placebo	Phase 2

Detailed Description

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Naltrexone	Drug: Naltrexone; daily; Other Names: Revia
Placebo Comparator: B Placebo	Drug: Placebo; daily

Outcome Measures

Primary Outcome Measures

1. Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) [K-YBOCS is done at each visit by the investigator.]

   The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. men and women age 21-75

2. current DSM-IV kleptomania.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination

2. history of seizures

3. myocardial infarction within 6 months

4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential

5. clinically significant suicidality

6. current or recent (past 3 months) DSM-IV substance abuse or dependence

7. illegal substance within 2 weeks of study initiation

8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline

9. initiation of a psychotropic medication within 2 months prior to study inclusion

10. previous treatment with naltrexone

11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Jon E Grant, MD, JD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00332579
• Other Study ID Numbers: 0602M82626
• First Posted: Jun 1, 2006
• Last Update Posted: Jul 29, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by University of Minnesota: Compulsive Shoplifting; Kleptomania; Compulsive Stealing
• Additional relevant MeSH terms: Disruptive, Impulse Control, and Conduct Disorders; Naltrexone

Study Results

Participant Flow

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.	Placebo tablets (identical to naltrexone pills) taken by mouth daily.
Period Title: Overall Study
STARTED	12	13
COMPLETED	11	12
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Naltrexone	Placebo	Total
Arm/Group Description	Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.	Placebo tablets (identical to naltrexone pills) taken by mouth daily.	Total of all reporting groups
Overall Participants	12	13	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	13 100%	25 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.3 (12.2)	41.4 (12.7)	42.6 (12.4)
Sex: Female, Male (Count of Participants)
Female	8 66.7%	10 76.9%	18 72%
Male	4 33.3%	3 23.1%	7 28%
Region of Enrollment (participants) [Number]
United States	12 100%	13 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
Description	The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
Time Frame	K-YBOCS is done at each visit by the investigator.

Outcome Measure Data

Analysis Population Description

Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).

Arm/Group Title	Naltrexone	Placebo
Arm/Group Description	Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.	Placebo tablets (identical to naltrexone pills) taken by mouth daily.
Measure Participants	12	13
Mean (Standard Deviation) [units on a scale]	3.83 (2.86)	11.46 (7.76)

Adverse Events

Arm/Group Title	Naltrexone		Placebo
Arm/Group Description	Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.		Placebo tablets (identical to naltrexone pills) taken by mouth daily.
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	0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Naltrexone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/13 (38.5%)		2/12 (16.7%)
Gastrointestinal disorders
Nausea	3/13 (23.1%)	3	1/12 (8.3%)	1
General disorders
Insomnia	1/13 (7.7%)	1	0/12 (0%)	0
Dry Mouth	1/13 (7.7%)	1	0/12 (0%)	0
Headache	0/13 (0%)	0	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

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.