Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study

Abstract

Objective: To evaluate exercise as a treatment for stimulant use disorders.

Methods: The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data.

Results: Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2).

Conclusions: The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose.

Trial registration: ClinicalTrials.gov identifier: NCT01141608.

Conflict of interest statement

Potential Conflicts of Interest:

Dr Trivedi has been an advisor/consultant and received fees from: Alkermes, AstraZeneca, Cerecor, Eli Lilly & Company, Lundbeck, Naurex, Neuronetics, Otsuka Pharmaceuticals, Pamlab, Pfizer Inc., SHIRE Development and Takeda. In addition, Dr. Trivedi has received grants/research support from: National Institute of Mental Health (NIMH) and National Institute on Drug Abuse (NIDA).

Dr Greer has received honoraria, speakers or advisory boards and/or consultant fees from H. Lundbeck A/S.

Dr Warden currently owns stock in Pfizer, Inc. and has owned stock in Bristol-Myers Squibb Company within the last five years.

Dr Nunes has received medication from Alkermes (vivitrol) for a NIDA funded research study on treatment of opioid dependence in recent years, and has served as an unpaid consultant to Alkermes at an advisory meeting about planning a study on treatment of opioid dependence.

Dr Rethorst, Dr Carmody, Mr Bruce Grannemann, Dr Walker, Dr Shores-Wilson, Dr Stoutenberg, Dr Oden, Dr Silverstein, Dr Hodgkins, Dr Love, Dr Seamans, Dr Stotts, Dr Causey, Dr Reed, Dr Rinaldi, Dr Myrick, Michele Straus, Dr Liu, Dr Lindblad, Dr Church and Dr Blair report no disclosures and conflicting interests.

© Copyright 2017 Physicians Postgraduate Press, Inc.

Figures

Figure 1. CONSORT Diagram

Note. In the Allocation row, “received allocated intervention” refers to the fact that all eligible participants were assigned to an intervention; however, this does not account for non- adherence. Because the analyses were intent to treat, they were conducted on all participants who were randomized to an intervention, regardless of their adherence to the intervention.

Figure 2. Adherence Adjusted Analyses

Independent simple regressions of percent of abstinent days on adherence as defined by percent of intervention sessions attended. Vertical reference lines mark the significantly different means of percent adherence in the two treatment groups.