Exercise as a Treatment for Substance Use Disorders Protocol (STRIDE)
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|ClinicalTrials.gov Identifier: NCT01141608|
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : September 11, 2018
Last Update Posted : September 3, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Stimulant Abuse and Dependence||Other: Vigorous Intensity High Dose Exercise Other: Health Education Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)|
|Actual Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Vigorous Intensity High Dose Exercise
Usual Care Augmented with Vigorous Intensity High Dose Exercise
Other: 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.
Other Name: Exercise
Experimental: Health Education Intervention
Health Education Intervention
Other: 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 Name: Exercise
- Percent Days Abstinent [ Time Frame: single value calculated based on TLFB data during days 22-84 ]Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week.
- Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB) [ Time Frame: 12 weeks ]
- Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief) [ Time Frame: 12 weeks ]
- Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) [ Time Frame: 12 weeks ]
- Time to Dropout From Substance Abuse Treatment [ Time Frame: 12 weeks ]
- Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) [ Time Frame: 9 months ]
- Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) [ Time Frame: 9 months ]
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female age 18-65.
- 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.
- Evidence of general medical condition or other abnormality that contraindicates use of exercise, based on the Medical Screening Visit.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141608
|United States, Colorado|
|Denver, Colorado, United States, 80236|
|United States, Florida|
|Gateway Community Services|
|Jacksonville, Florida, United States, 32204|
|United States, Missouri|
|Gibson Recovery Center, Inc.|
|Cape Girardeau, Missouri, United States, 63703|
|United States, New York|
|New York, New York, United States, 10019|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29401|
|Columbia, South Carolina, United States, 29203|
|United States, Texas|
|Nexus Recovery, Inc.|
|Dallas, Texas, United States, 75228|
|Houston, Texas, United States, 77080|
|Principal Investigator:||Madhukar H Trivedi, M.D.||UT Southwestern Medical Center|
|Responsible Party:||Madhukar H. Trivedi, MD, Principal Investigator, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
5U10DA020024-05 ( U.S. NIH Grant/Contract )
|First Posted:||June 10, 2010 Key Record Dates|
|Results First Posted:||September 11, 2018|
|Last Update Posted:||September 3, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||"Per CTN policy, study data is shared within 18-months of study completion. Data that has been shared has been completely de-identified to prevent linkages to individual research participants. This includes removal of all Personal Health Information (PHI) and indirect identifiers that are not listed as PHI but could lead to 'deductive disclosure' such as comment fields and site numbers."|
|Time Frame:||18 months following study completion.|