A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder.
Julianne D Jett, Diana Tyutyunnyk, Rachael Beck, Katharine Palmer, Danielle Ryan, Jesus Sanchez, Douglas L Weeks, Sterling M McPherson, Naomi Chaytor, Brian Kiluk, Martin A Javors, Brett C Ginsburg, Sean Murphy, Nathalie Hill-Kapturczak, Michael G McDonell
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引用次数: 0
Abstract
Background: Contingency management (CM) is an intervention for alcohol use disorder (AUD) that reinforces abstinence, as confirmed by alcohol biomarkers. CM is usually brief (12-16 weeks) despite evidence that longer interventions have better long-term outcomes. Most CM models are in-person which can also be a barrier for treatment. Studies of longer duration telehealth-based CM models are needed.
Aims: To determine if a telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention and 12-month follow-up. We will evaluate the impact of CM on alcohol-related outcomes, determine if Addiction Neuroclinical Assessment variables are associated with outcomes in follow-up, and whether savings related to decreased alcohol use offset intervention costs.
Methods: Adults with AUD residing in the United States will be recruited via online advertising. Research procedures will be conducted virtually. Participants who submit a PEth-positive blood sample (≥20 ng/mL) at enrollment will be randomized to 26 weeks of either 1) online cognitive behavior therapy (CBT4CBT) with rewards not contingent on PEth results (Control group) or 2) CBT4CBT with a maximum of $1,820 of rewards contingent on PEth results (CM group). Efficacy outcomes of PEth-negative tests (primary) and PEth-defined excessive drinking (≥200 ng/mL; secondary) will be assessed. Predictors of intervention outcomes and economic viability will also be investigated.
Discussion: If this telehealth-delivered PEth-based CM intervention reduces alcohol use and is cost-effective, it could be used to provide effective treatment to millions of individuals with AUD who do not receive in-person care.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.