TY - JOUR
T1 - Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037
T2 - Study protocol for a randomized controlled trial
AU - Trivedi, Madhukar H.
AU - Greer, Tracy L.
AU - Grannemann, Bruce D.
AU - Church, Timothy S.
AU - Somoza, Eugene
AU - Blair, Steven N.
AU - Szapocznik, Jose
AU - Stoutenberg, Mark
AU - Rethorst, Chad
AU - Warden, Diane
AU - Ring, Kolette M.
AU - Walker, Robrina
AU - Morris, David W.
AU - Kosinski, Andrzej S.
AU - Kyle, Tiffany
AU - Marcus, Bess
AU - Crowell, Becca
AU - Oden, Neal
AU - Nunes, Edward
N1 - Funding Information:
We are particularly grateful to our Protocol Development Team, which guided the STRIDE Study design and includes Steven N. Blair, P.E.D.; Dan G. Blazer, M.D., M.P.H., Ph.D.; Kathleen Brady, M.D., Ph.D.; Timothy Church, M.D., M.P.H., Ph.D.; Tracy L. Greer, Ph.D.; Petra Jacobs, M.D.; Eve Jelstrom, CRNA, M. B.A.; Andrzej Kosinski, Ph.D.; Michael Levy, Ph.D.; Tiffany L. Linkovich Kyle, Ph. D.; David Liu, M.D.; Yuliya Lokhnygina, Ph.D.; Bess H. Marcus, Ph.D.; Edward V. Nunes, M.D.; John P. Rotrosen, M.D.; Jeffrey T. Sharp, M.S.; Eugene Somoza, M.D., Ph.D.; Michele M. Straus, RPh, M.S.; Jose Szapocznik, Ph.D.; Madhukar H. Trivedi, M.D.; Paul Wakim, Ph.D.; and Diane Warden, M.B.A., Ph.D. We are also greatly appreciative of the RRTC personnel from the Ohio Valley Node and Florida Node of the Clinical Trials Network, who were instrumental in the development of this trial, sharing valuable knowledge and expertise with this team. We also appreciate the expertise and guidance of the STRIDE Executive Committee which includes Colleen Allen, M.P.H., CCRA; Steven N. Blair, P.E.D.; Jack Chally, M.B.A.; Timothy Church, M.D., M.P.H., Ph.D.; Becca Crowell, M.Ed., Ed.S.; Eve Jelstrom, CRNA, M.B.A.; Tracy L. Greer, Ph.D.; Tiffany L. Linkovich Kyle, Ph.D.; David Liu, M.D.; Bess H. Marcus, Ph.D.; Edward V. Nunes, M.D.; Neal Oden Ph.D.; John P. Rotrosen, M.D.; Eugene Somoza, M.D., Ph.D.; James L. Sorensen, Ph.D.; Michele M. Straus, RPh, M.S.; Madhukar H. Trivedi, M.D.; Paul Van Veldhuisen, Ph.D.; Diane Warden, M.B.A., Ph.D.; and Jeremy Wolff, B.A. We are also very grateful to Barbara Henry for her assistance in preparing the manuscript prior to submission and to Carol A. Tamminga, M.D., Communities Foundation of Texas, Inc. Chair in Brain Science, and Chair, Department of Psychiatry, University of Texas Southwestern Medical Center for administrative support. This work was supported by the National Institute on Drug Abuse through the Clinical Trials Network for the Texas Node [3U10DA020024-06S1], Madhukar H. Trivedi, M.D., Principal Investigator; and the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study [2U10DA020024-06], Madhukar H. Trivedi, M.D., Lead Investigator.
Funding Information:
Madhukar H. Trivedi, M.D. is a consultant to or on speaker bureaus for Abbott Laboratories, Inc., Abdi Ibrahim, Akzo (Organon Pharmaceuticals Inc.), AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc., Cyberonics Inc., Eli Lilly & Company, Evotec, Fabre Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica Products, LP, Johnson & Johnson PRD, Meade Johnson, Medtronic, Neuronetics, Otsuka Pharmaceuticals, Parke-Davis Pharmaceuticals, Inc., Pfizer Inc., Sepracor, SHIRE Development, Solvay Pharmaceuticals, VantagePoint, and Wyeth-Ayerst Laboratories. He receives research support from the Agency for Healthcare Research and Quality (AHRQ), Corcept Therapeutics, Inc., Cyberonics, Inc., Merck, National Alliance for Research in Schizophrenia and Depression, National Institute of Mental Health, National Institute on Drug Abuse, Novartis, Pharmacia & Upjohn, Predix Pharmaceuticals (Epix), Solvay Pharmaceuticals, Inc., and Targacept. Tracy L. Greer Ph.D. has received research support from the National Alliance for Research in Schizophrenia and Depression. Bruce D. Grannemann, M.A. declares that there is no conflict of interest. Timothy S. Church, M.D., Ph.D., M.P.H. declares that there is no conflict of interest. Eugene Somoza, M.D., Ph.D. declares that there is no conflict of interest. Steven N. Blair, P.E.D. declares that there is no conflict of interest. Jose Szapocznik, Ph.D. declares that there is no conflict of interest. Mark Stoutenberg, Ph.D. declares that there is no conflict of interest. Chad Rethorst, Ph.D. declares that there is no conflict of interest. Diane Warden, Ph.D., M.B.A. has owned stock in Bristol Myers Squibb and Pfizer, Inc. in the last 5 years and has received funding from the National Alliance for Research in Schizophrenia and Depression. David W. Morris, Ph.D. declares that there is no conflict of interest. Andrzej S. Kosinski, Ph.D. declares that there is no conflict of interest. Tiffany Kyle, Ph.D. declares that there is no conflict of interest. Bess Marcus, Ph.D. declares that there is no conflict of interest. Becca Crowell, M.Ed., Ed.S. declares that there is no conflict of interest. Neal Oden, Ph.D. declares that there is no conflict of interest. Edward Nunes, M.D. has received funding from NIDA for grants K24DA022412 (PI: Nunes) and U10DA13035 (PI: Nunes).
PY - 2011/9/19
Y1 - 2011/9/19
N2 - 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/Design: 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. Clinical Trials Registry: ClinicalTrials.gov, NCT01141608. http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1.
AB - 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/Design: 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. Clinical Trials Registry: ClinicalTrials.gov, NCT01141608. http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1.
KW - Behavioral intervention
KW - Exercise
KW - Health education
KW - Stimulant abuse
KW - Stimulant dependence
UR - http://www.scopus.com/inward/record.url?scp=80052858575&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80052858575&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-12-206
DO - 10.1186/1745-6215-12-206
M3 - Article
C2 - 21929768
AN - SCOPUS:80052858575
SN - 1745-6215
VL - 12
JO - Trials
JF - Trials
M1 - 206
ER -