Trial Outcomes & Findings for Contingency Management of Alcohol Abuse in the Severely Mentally ILL (NCT NCT01567943)

Results Overview

Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

123 participants

Primary outcome timeframe

Over 16 weeks of treatment (repeated measure)

Results posted on

2017-02-23

Participant Flow

123 participants were enrolled, but only 79 met criteria to be randomized. Criteria for randomization included: EtG-positive urine sample during 4-week pre-randomization phase of the study, and adequate attendance during the pre-randomization phase.

Participant milestones

Participant milestones
Measure	Contingency Management Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence	Non-contingent Control Group Treatment as usual plus reinforcement for attendance	Pre-randomization Drop-out These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.
Overall Study STARTED	40	39	44
Overall Study COMPLETED	26	29	44
Overall Study NOT COMPLETED	14	10	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contingency Management of Alcohol Abuse in the Severely Mentally ILL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contingency Management n=40 Participants Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence	Non-contingent Control Group n=39 Participants Treatment as usual plus reinforcement for attendance	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants	39 Participants n=107 Participants	79 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	44.55 years STANDARD_DEVIATION 9.92 • n=99 Participants	46.23 years STANDARD_DEVIATION 10.55 • n=107 Participants	45.38 years STANDARD_DEVIATION 10.24 • n=206 Participants
Gender Female	14 Participants n=99 Participants	15 Participants n=107 Participants	29 Participants n=206 Participants
Gender Male	26 Participants n=99 Participants	24 Participants n=107 Participants	50 Participants n=206 Participants
Region of Enrollment United States	40 Participants n=99 Participants	39 Participants n=107 Participants	79 Participants n=206 Participants

PRIMARY outcome

Timeframe: Over 16 weeks of treatment (repeated measure)

Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.

Outcome measures

Outcome measures
Measure	Contingency Management n=40 Participants Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence	Non-contingent Control Group n=39 Participants Treatment as usual plus reinforcement for attendance
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine	408.86 EtG Value (nanograms per milileter) Standard Error 39.57	734.79 EtG Value (nanograms per milileter) Standard Error 40.66

SECONDARY outcome

Timeframe: During 16 weeks of treatment

Outcome measures

Outcome measures
Measure	Contingency Management n=40 Participants Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence	Non-contingent Control Group n=39 Participants Treatment as usual plus reinforcement for attendance
Change in Intensive Outpatient Substance Abuse Treatment Attendance	57 percentage of addiction tx attended Standard Deviation 34	53 percentage of addiction tx attended Standard Deviation 37

SECONDARY outcome

Timeframe: through 7 months of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through 7 months of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: entire study period, and three month prior and after study involvement

(jail bookings, ER visits, mental health and substance abuse service utilization)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: throughout 7 months of study

Brief Symptom Inventory; Positive and Negative Symptom Scale

Outcome measures

Outcome data not reported

Adverse Events

Contingency Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-contingent Control Group

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

Michael McDonell

Washington State University

Phone: 509 368-6967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place