title: Stimulant reduction intervention using dosed exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  There is a 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. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1.
authors.affiliation: The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9119, USA. madhukar.trivedi@utsouthwestern.edu
authors.forename: Madhukar H
authors.initials: MH
authors.lastname: Trivedi
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Greer
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Grannemann
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Church
authors.forename: Eugene
authors.initials: E
authors.lastname: Somoza
authors.forename: Steven N
authors.initials: SN
authors.lastname: Blair
authors.forename: Jose
authors.initials: J
authors.lastname: Szapocznik
authors.forename: Mark
authors.initials: M
authors.lastname: Stoutenberg
authors.forename: Chad
authors.initials: C
authors.lastname: Rethorst
authors.forename: Diane
authors.initials: D
authors.lastname: Warden
authors.forename: Kolette M
authors.initials: KM
authors.lastname: Ring
authors.forename: Robrina
authors.initials: R
authors.lastname: Walker
authors.forename: David W
authors.initials: DW
authors.lastname: Morris
authors.forename: Andrzej S
authors.initials: AS
authors.lastname: Kosinski
authors.forename: Tiffany
authors.initials: T
authors.lastname: Kyle
authors.forename: Bess
authors.initials: B
authors.lastname: Marcus
authors.forename: Becca
authors.initials: B
authors.lastname: Crowell
authors.forename: Neal
authors.initials: N
authors.lastname: Oden
authors.forename: Edward
authors.initials: E
authors.lastname: Nunes
mesh_terms: D000697:Central Nervous System Stimulants; D002985:Clinical Protocols; D005081:Exercise Therapy; D006266:Health Education; D006801:Humans; D017063:Outcome Assessment, Health Care; D012107:Research Design; D019966:Substance-Related Disorders / Q000628:therapy*
chemical_list: D000697:Central Nervous System Stimulants