Trial Outcomes & Findings for Acamprosate in the Treatment of Pathological Gambling (NCT NCT00571103)

Results Overview

The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

8 weeks minus baseline

Results posted on

2017-05-25

Participant Flow

Subjects were recruited through newspaper advertising, word of mouth, and lab registries. Subjects were seen in each doctor's clinic respectively.

Two subjects failed to meet study criteria (their severity of gambling was too low)and 6 subjects were lost to follow-up after the screening visit (Visit One).

Participant milestones

Participant milestones
Measure	Open Label All subjects received the drug.
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label All subjects received the drug.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Acamprosate in the Treatment of Pathological Gambling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=28 Participants All subjects received the drug.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks minus baseline

The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.

Outcome measures

Outcome measures
Measure	Open Label n=26 Participants All subjects received the drug.
The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).	-.985 units on a scale Standard Error .158

SECONDARY outcome

Timeframe: 8 weeks minus baseline

Population: A total of 39 participants were screened by phone and 5 failed to meet screening criteria and were excluded; 6 did not return for the baseline visit because of follow-up loss or choosing to discontinue participation. of the remaining 28 patients, 1 discontinued and another was lost to follow-up after the baseline visit. That left 26 subjects.

The G-SAS is a 12 item self-report instrument that reflects the subjects urges to gamble and the subjects gambling behavior. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms) with a total score range from 0 to 48. The CGI-I is a 7 point scale requiring the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill patients.

Outcome measures

Outcome measures
Measure	Open Label n=26 Participants All subjects received the drug.
The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression - Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression - Severity Scale. G-SAS	-1.117 units on a scale Standard Error .228
The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression - Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression - Severity Scale. CGI-I	-.145 units on a scale Standard Error .031
The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression - Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression - Severity Scale. CGI-S	-.199 units on a scale Standard Error .035

Adverse Events

Open Label

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. Donald W Black

University of Iowa Carver College of Medicine

Phone: 319-3534431

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place