Hurt 2018.
Study characteristics | ||
Methods | Country: USA Study design: phase II/III randomised quadruple‐blind placebo‐controlled trial Study period: July 2011‐April 2013 |
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Participants | 33 adult alcohol‐dependent smokers | |
Interventions | Varenicline 1 mg 2 x day for 12 weeks vs placebo | |
Outcomes | PA at 12 weeks (EoT), and at 6 months Abstinence self‐reported and biochemically validated by exhaled CO | |
Notes | Study results posted on www.clinicaltrials.gov May 2014 Study funding: "This current study was supported by grant R21 DA30645 to Dr Richard D. Hurt and Pfizer IIR to Dr J. Taylor Hays" Author declaration of interests: "R.T.H. reports research grants from Pfizer and the NIH. J.T.H. reports research grants from Pfizer. J.O.E. reports grants from Pfizer during the conduct of the study and grants from Takeda, the U.S. Department of Defense and the NIH outside the submitted work. R.D.H. reports a research grant from the NIH. All other others have nothing to disclose" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated "randomized" but method not reported |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Pharmacy personnel dispensed study medication into containers labeled with study identification numbers. Study participants, investigators, and pharmacy staff were blinded to treatment assignment." Abstinence biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | High risk | High attrition rates: 4/16 varenicline group (1 withdrawal, 3 lost), 12/17 placebo group (7 withdrawals, 5 lost) |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes from NCT record all reported in results paper |