Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

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 eligible and interested participants who provide informed consent 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 receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. 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.ClinicalTrials.gov, NCT01141608http:/ / clinicaltrials.gov/ ct2/ show/ NCT01141608?term=Stimulant+Reductio n+Intervention+using+Dosed+Exercise &rank=1 webciteThere is a need for novel approaches to the treatment of stimulant use disorders. Stimulant use disorders are chronic, relapsing illnesses with few highly efficacious treatments [1]. In control conditions (Treatment as Usual; TAU) for substance use disorders, typically only about 13% of participants achieve abstinence [1]. Abstinence rates for treatments designed to augment TAU vary widely - ranging from 14-60%[2-5] - depending on the outcome variable and primary endpoint selected. Currently, the best treatments for cocaine and other stimulant use disorders are behavioral treatments that combine cognitive behavioral therapy (CBT) with contingency management [1,6]. However, it is clear tha