A complier average causal effect analysis of the Stimulant Reduction Intervention using dosed exercise study

• Published in: Contemporary clinical trials communications 2018-06, Vol.10, p.1-8
• Main Authors: Carmody, Thomas, Greer, Tracy L, Walker, Robrina, Rethorst, Chad D, Trivedi, Madhukar H
• Format: Article
• Language: English
• Subjects: Clinical trials network; Complier average causal effects; Exercise intervention; Health education; Other; Stimulant abuse or dependence
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2018.02.001

Abstract Objective Exercise is a promising treatment for substance use disorders, yet an intention-to-treat analysis of a large, multi-site study found no reduction in stimulant use for exercise versus health education. Exercise adherence was sub-optimal; therefore, secondary post-hoc complier average causal effects (CACE) analysis was conducted to determine the potential effectiveness of adequately dosed exercise. Method The STimulant use Reduction Intervention using Dosed Exercise study was a randomized controlled trial comparing a 12 kcal/kg/week (KKW) exercise dose versus a health education control conducted at nine residential substance use treatment settings across the U.S. that are affiliated with the National Drug Abuse Treatment Clinical Trials Network. Participants were sedentary but medically approved for exercise, used stimulants within 30 days prior to study entry, and received a DSM-IV stimulant abuse or dependence diagnosis within the past year. A CACE analysis adjusted to include only participants with a minimum threshold of adherence (at least 8.3 KKW) and using a negative-binomial hurdle model focused on 218 participants who were 36.2% female, mean age 39.4 years ( SD  = 11.1), and averaged 13.0 ( SD  = 9.2) stimulant use days in the 30 days before residential treatment. The outcome was days of stimulant use as assessed by the self-reported TimeLine Follow Back and urine drug screen results. Results The CACE-adjusted analysis found a significantly lower probability of relapse to stimulant use in the exercise group versus the health education group (41.0% vs. 55.7%, p