Trial Outcomes & Findings for Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble (NCT NCT01215357)

Results Overview

This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2024-05-14

Participant Flow

Recruitment started Sept 2010 and finished June 2011

See exclusion criteria

Participant milestones

Participant milestones
Measure	Ecopipam (50 or 100 mg, as Needed) Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
Overall Study STARTED	34
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Ecopipam (50 or 100 mg, as Needed) Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
Overall Study Withdrawal by Subject	3
Overall Study Protocol Violation	9

Baseline Characteristics

Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ecopipam 50 or 100 mg, as Needed n=34 Participants Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.8 years STANDARD_DEVIATION 13.35 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Patients completing all visits

This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.

Outcome measures

Outcome measures
Measure	Ecopipam 50 mg or 100 mg as Needed n=28 Participants Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling	13.9 YBOCS score Standard Deviation 8.79

SECONDARY outcome

Timeframe: 6 weeks

All side effects of the drug will be monitored and recorded

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

It is expected that there will be decreases in this scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study

Outcome measures

Outcome data not reported

Adverse Events

Ecopipam 50 or 100 mg, as Needed

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ecopipam 50 or 100 mg, as Needed n=34 participants at risk Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
Nervous system disorders Sedation	11.8% 4/34 • Number of events 4 • 8 weeks
Nervous system disorders Anxiety	8.8% 3/34 • Number of events 3 • 8 weeks
Gastrointestinal disorders Constipation	5.9% 2/34 • Number of events 2 • 8 weeks
Eye disorders Rhinorrhea	5.9% 2/34 • Number of events 2 • 8 weeks
Gastrointestinal disorders Vomiting	5.9% 2/34 • Number of events 2 • 8 weeks

Additional Information

Dr. Richard Chipkin

Psyadon Pharmaceuticals

Phone: 301-919-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60