Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) – CTN 0037: Study protocol for a randomized controlled trial.

There is need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. This article presents the rationale, design considerations, and study design of the National Drug Abuse Treatment Clinical Trials Network (CTN) Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study (protocol CTN-0037). STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty participants will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will also receive treatment as usual. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session. STRIDE is one of the first studies conducted within the CTN that is specifically designed as a first test of a new intervention in a specific disorder. As such, it will not only test the efficacy and effectiveness of this intervention for stimulant abuse and dependence, but also provide information about conducting this type of study in the context of a network of community treatment programs.

Related protocols: CTN-0037