Exercise as a Treatment for Substance Use Disorders Protocol
NCT ID: NCT01141608
Last Updated: 2020-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2010-06-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vigorous Intensity High Dose Exercise
Usual Care Augmented with Vigorous Intensity High Dose Exercise
Vigorous Intensity High Dose Exercise
Participants randomized to the exercise condition will begin with supervised exercise 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. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.
Health Education Intervention
Health Education Intervention
Health Education Intervention
Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
Interventions
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Vigorous Intensity High Dose Exercise
Participants randomized to the exercise condition will begin with supervised exercise 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. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.
Health Education Intervention
Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to residential setting and receiving substance use treatment.
* Ability to understand and willingness to provide written informed consent.
* Agree to remain in facility for authorized treatment of about 21-30 days.
* Willing to provide contact information.
* Self-reported use of stimulant drug (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the 30 days prior to admission for treatment.
* Meets DSM-IV criteria for substance abuse or dependence for stimulants (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the last 12 months.
* Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
* Body mass index (BMI)≤40 kg/m2 or BMI 40 \>kg/m2 and cleared by medical personnel to exercise.
* Able to comprehend and communicate in English.
Exclusion Criteria
* Current opiate dependence.
* Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
* Pregnancy.
* Significant physical activity, defined as aerobic exercise more than 3 times per week for 20 minutes or more, completed consistently for the three months prior to study enrollment.
* Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
* Concomitant treatments: beta blockers; methadone, buprenorphine, or any other opioid replacement therapies.
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Madhukar H. Trivedi, MD
Principal Investigator
Principal Investigators
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Madhukar H Trivedi, M.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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Arapahoe House
Denver, Colorado, United States
Gateway Community Services
Jacksonville, Florida, United States
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, United States
St. Luke's-Roosevelt
New York, New York, United States
Penn Presbyterian
Philadelphia, Pennsylvania, United States
Charleston VAMC
Charleston, South Carolina, United States
Morris Village
Columbia, South Carolina, United States
Nexus Recovery, Inc.
Dallas, Texas, United States
Memorial Hermann
Houston, Texas, United States
Countries
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References
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Jha MK, Schatzberg A, Minhajuddin A, Chin Fatt C, Mayes TL, Trivedi MH. Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project. J Clin Psychiatry. 2021 Apr 13;82(3):20m13740. doi: 10.4088/JCP.20m13740.
Trombello JM, Killian MO, Liao A, Sanchez K, Greer TL, Walker R, Grannemann B, Rethorst CD, Carmody T, Trivedi MH. Psychometrics of the Self-Report Concise Associated Symptoms Tracking Scale (CAST-SR): Results From the STRIDE (CTN-0037) Study. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11707. doi: 10.4088/JCP.17m11707.
Trivedi MH, Greer TL, Rethorst CD, Carmody T, Grannemann BD, Walker R, Warden D, Shores-Wilson K, Stoutenberg M, Oden N, Silverstein M, Hodgkins C, Love L, Seamans C, Stotts A, Causey T, Szucs-Reed RP, Rinaldi P, Myrick H, Straus M, Liu D, Lindblad R, Church T, Blair SN, Nunes EV. Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study. J Clin Psychiatry. 2017 Sep/Oct;78(8):1075-1082. doi: 10.4088/JCP.15m10591.
Warden D, Sanchez K, Greer T, Carmody T, Walker R, Dela Cruz A, Toups M, Rethorst C, Trivedi MH. Demographic and clinical characteristics of current comorbid psychiatric disorders in a randomized clinical trial for adults with stimulant use disorders. Psychiatry Res. 2016 Dec 30;246:136-141. doi: 10.1016/j.psychres.2016.09.007. Epub 2016 Sep 15.
Trivedi MH, Greer TL, Grannemann BD, Church TS, Somoza E, Blair SN, Szapocznik J, Stoutenberg M, Rethorst C, Warden D, Ring KM, Walker R, Morris DW, Kosinski AS, Kyle T, Marcus B, Crowell B, Oden N, Nunes E. Stimulant reduction intervention using dosed exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial. Trials. 2011 Sep 19;12:206. doi: 10.1186/1745-6215-12-206.
Other Identifiers
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STU 122009-043
Identifier Type: -
Identifier Source: org_study_id
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