Trial Outcomes & Findings for Insomnia and Drug Relapse Risk (NCT NCT00253890)

NCT ID: NCT00253890

Last Updated: 2013-12-11

Results Overview

Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 137 participants
• Primary outcome timeframe: Baseline to 1-month
• Results posted on: 2013-12-11

Participant Flow

Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.

Participant milestones

Measure	Trazodone 50-150mg at bedtime	Placebo 1-3 capsules at bedtime
Overall Study STARTED	69	68
Overall Study COMPLETED	62	61
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insomnia and Drug Relapse Risk

Baseline characteristics by cohort

Measure	Trazodone n=69 Participants 50-150mg at bedtime	Placebo n=68 Participants 1-3 at bedtime	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38.0 years STANDARD_DEVIATION 8.8 • n=5 Participants	38.5 years STANDARD_DEVIATION 8.7 • n=7 Participants	38.2 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	39 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	29 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	68 participants n=7 Participants	137 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1-month

Population: Intent to Treat

Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Outcome measures

Measure	Trazodone n=67 Participants 50-150mg at bedtime	Placebo n=67 Participants 1-3 capsules at bedtime
Sleep Quality, as Measured by Total Sleep Time	339 minutes Standard Deviation 136	329 minutes Standard Deviation 124

Adverse Events

Trazodone

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. Michael D. Stein, MD

Butler Hospital

Phone: 401-455-6646

Email: mstein@butler.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place