Trial Outcomes & Findings for Investigation of Naltrexone for Pathological Gambling (NCT NCT01057862)

Results Overview

The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Weekly/bi-weekly visits

Results posted on

2017-10-13

Participant Flow

Enrollment was dependent on referrals from several gambling related clinics in the state of CT and unfortunately there were very few referrals causing the study to end with much lower numbers of study subjects than anticipated.

Participant milestones

Participant milestones
Measure	Naltrexone Naltrexone: Targeted dosage of 50mg PO daily	Placebo
Overall Study STARTED	5	4
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone Naltrexone: Targeted dosage of 50mg PO daily	Placebo
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Investigation of Naltrexone for Pathological Gambling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=5 Participants Naltrexone: Targeted dosage of 50mg PO daily	Placebo n=4 Participants Placebo	Total n=9 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 9.9 • n=5 Participants	52.75 years STANDARD_DEVIATION 9 • n=7 Participants	55.11 years STANDARD_DEVIATION 9.17 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly/bi-weekly visits

Population: Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.

The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.

Outcome measures

Outcome measures
Measure	Naltrexone n=5 Participants Naltrexone: Targeted dosage of 50mg PO daily	Placebo n=4 Participants Placebo
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) Baseline	16.0 units on a scale Standard Deviation 7.35	17.0 units on a scale Standard Deviation 13.54
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) End of Study	10.0 units on a scale Standard Deviation 9.35	4.0 units on a scale Standard Deviation 5.65

SECONDARY outcome

Timeframe: Weekly/bi-weekly visits

Population: Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.

The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 - 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20.

Outcome measures

Outcome measures
Measure	Naltrexone n=5 Participants Naltrexone: Targeted dosage of 50mg PO daily	Placebo n=4 Participants Placebo
Gambling Symptom Assessment Scale (G-SAS) Baseline	26.8 units on a scale Standard Deviation 11.73	24.75 units on a scale Standard Deviation 11.53
Gambling Symptom Assessment Scale (G-SAS) End of Study	12.6 units on a scale Standard Deviation 9.45	1.0 units on a scale Standard Deviation 1.41

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc N Potenza

Yale University

Phone: 2037373553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place