Patient-reported sleep outcomes in randomized-controlled trials in persons with substance use disorders: A systematic review

Abstract

Background: Sleep disturbances and disorders are a common and sometimes recalcitrant problem in persons recovering from substance use disorders (SUDs). As such, several randomized-controlled trials (RCTs) have been conducted to address sleep disturbances in a variety of SUD subpopulations and clinical scenarios. The goal of this systematic review was to collate patient-reported sleep outcomes used in past SUD-related RCTs to provide guidance for future sleep research in persons with SUDs.

Methods: This systematic review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on May 7th, 2020 (CRD42020182004). Studies were included if they were peer-reviewed manuscripts describing RCTs in an SUD population.

Results: The initial search yielded 13,403 candidate articles, and 76 met a priori criteria and were included in this review. Thirty-five (46.1%) assessed sleep as a primary outcome (i.e., sleep improvement was the primary goal of the research) and 41 (53.9%) assessed sleep as a secondary outcome (i.e., sleep improvement was an important outcome, but not the primary outcome). The most commonly used measures included the Pittsburgh Sleep Quality Index, the Insomnia Severity Index, and sleep diaries. However, multiple additional sleep assessments were also used, including visual analogue and Likert scales.

Conclusions: The field of addiction medicine would benefit from a streamlined approach in assessing patient-reported sleep in RCTs, including commonly used and validated assessments of sleep quality, inserting daily or repeated measures into RCTs, and including questionnaires that assess clinically relevant insomnia or other sleep disorders.

Keywords: Alcohol; Cannabis; Clinical trial; Cocaine; Insomnia; Methamphetamine; Opioid; Outcomes; Sleep; Substance use disorder.