McRae‐Clark 2015.
Methods | Randomised placebo‐controlled trial | |
Participants | Setting: outpatient (no further details on site, appears to be a single site). Scheduled duration 12 weeks Participants: 175 adults, current cannabis dependence by DSM‐IV Group sizes: group 1, 88; group 2, 87 Groups similar on demographics and clinical characteristics at baseline Mean age 24 years 77% male 64% Caucasian Exclusion criteria: current dependence on other substances except caffeine and nicotine, and significant psychiatric condition |
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Interventions | Group 1: buspirone, up to 60 mg/day Group 2: placebo Brief MET intervention and contingency management to encourage study retention as adjunct interventions |
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Outcomes | Participants with ≥ 1 negative urine test during treatment Point prevalence of abstinence by urine test at week 12 Number reporting adverse events |
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Notes | Funding: research grant (NIDA) 2 authors report previous pharmaceutical company funding |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Buspirone and placebo tablets were packaged in identical opaque gelatin capsules with lactose." Comment: it was likely that participants and treating clinicians were blind to group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind likely as indicated above, and only objective outcomes reported which are less likely to be affected by knowledge of group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Rates of attrition high, but similar in both groups. Missing data on cannabinoid urine tests counted as positive. |
Selective reporting (reporting bias) | Low risk | None apparent, published outcomes accorded with prospectively registered outcomes. |
Other bias | Low risk | None apparent |