Stein 2012.
| Methods | Randomised, double‐blind, placebo‐controlled trial | |
| Participants |
Insomnia diagnosis criteria (method of diagnosis): PSQI ≥ 6 Other diagnoses: participants were previously opioid dependent, receiving methadone for ≥ 1 month Number of participants randomised: n = 137 Trazodone: n = 69 Placebo: n = 68 Number of participants: n = 123 Trazodone: n = 62 Placebo: n = 61 Age, mean (SD) years: 38.2 (8.6) Trazodone: 38.0 (8.8) Placebo: 38.5 (8.7) Gender (M/F): 64/73 Trazodone: 35/34 Placebo: 29/39 Race/ethnicity: Total: 117 (85.4%) white, 10 (7.3%) African‐American, 10 (7.3%) Hispanic Placebo: 61 (89.7%) white, 2 (2.9%) African‐American, 5 (7.4%) Hispanic Country: USA Setting: multicentre; 8 different methadone maintenance clinics in the Providence, Rhode Island metropolitan area Included: PSQI ≥ 6; ability to read, speak and understand English; plans to continue methadone maintenance for ≥ 6 months Excluded: symptoms suggestive of psychotic disorder, schizophrenia, gross cognitive dysfunction, current use of trazodone or psychotropic medication (last 30 days), inability or refusal to terminate pro‐erectile agents, pregnancy, lactation or inability or refusal to use contraception for women, unstable housing such as a shelter or halfway house Withdrawals: n = 14 Trazodone: n = 7 Placebo: n = 7 Baseline imbalances: relatively more African‐American participants in the trazodone group (n = 8) than the placebo group (n = 2) |
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| Interventions |
Intervention: trazodone self‐administered 50‐150 mg at bedtime, so participants could self‐titrate to an effective dose of 50‐150 mg Comparator: placebo self‐administered at bedtime |
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| Outcomes |
Primary outcomes PSQI Minimum sleep period, minimum TST, SE, times awakened, restfulness rating reported Mean TST, mean sleep onset latency, mean SE, mean NAW, mean restfulness rating reported Secondary outcomes Objective sleep measures: SE, sleep period time, TST, stage 1 sleep %, stage 2 sleep %, SWS %, REM %, time awake %, arousal index, apnoea index Adverse effects |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence without stratification (Pg 66, "Treatment" paragraph 11) |
| Allocation concealment (selection bias) | Unclear risk | Details of the sequence and blinding were provided, but not of the allocation (Pg 66, "Treatment" paragraph 11) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding maintained by a staff member outside the project. Placebo "provided in identical capsule form" (Pg 66, paragraph 12) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 14/137 participants did not complete the 6 months study; no details given. |
| Selective reporting (reporting bias) | Unclear risk | No details given |
| Other bias | Low risk | Full disclosure; no conflict of interest |