Opiate Addiction, Poor Quality Sleep
Conditions
Keywords
sleep quality, methadone, substance use
Brief summary
The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
Detailed description
Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.
Interventions
DRUGTrazodone
50 mg 1-3 capsules at bedtime for 3 months
DRUGPlacebo
1-3 at bedtime
Sponsors
National Institute on Drug Abuse (NIDA)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Recent methadone maintenance enrollment * Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI) * No medical contraindications to trazodone
Exclusion criteria
* Methadone maintenance enrollment not recent * No sleep complaints as measured by the PSQI * Medical contraindications to trazodone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality, as Measured by Total Sleep Time | Baseline to 1-month | Number of minutes spent sleeping during sleep period, as measured by daily sleep diary. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.
Participants by arm
| Arm | Count |
|---|---|
| Trazodone 50-150mg at bedtime | 69 |
| Placebo 1-3 at bedtime | 68 |
| Total | 137 |
Baseline characteristics
| Characteristic | Placebo | Trazodone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 69 Participants | 137 Participants |
| Age Continuous | 38.5 years STANDARD_DEVIATION 8.7 | 38.0 years STANDARD_DEVIATION 8.8 | 38.2 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 68 participants | 69 participants | 137 participants |
| Sex: Female, Male Female | 39 Participants | 34 Participants | 73 Participants |
| Sex: Female, Male Male | 29 Participants | 35 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 68 |
| serious Total, serious adverse events | 0 / 69 | 0 / 68 |
Outcome results
Primary
Sleep Quality, as Measured by Total Sleep Time
Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
Time frame: Baseline to 1-month
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Sleep Quality, as Measured by Total Sleep Time | 339 minutes | Standard Deviation 136 |
| Placebo | Sleep Quality, as Measured by Total Sleep Time | 329 minutes | Standard Deviation 124 |
Comparison: Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.p-value: 0.05t-test, 2 sided