Exercise as a Treatment for Substance Use Disorders Protocol (NCT01141608) | Clinical Trial Compass
CompletedNot Applicable
Exercise as a Treatment for Substance Use Disorders Protocol
United States302 participantsStarted 2010-06
Plain-language summary
The purpose of this study is to investigate if health interventions (intensive exercise or health education) can be used to help improve substance abuse treatment. The primary objective of this protocol is to compare percent days of abstinence between Vigorous Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during a 12-week acute phase.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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-m…
What they're measuring
1
Percent Days Abstinent
Timeframe: single value calculated based on TLFB data during days 22-84
Trial details
NCT IDNCT01141608
SponsorUniversity of Texas Southwestern Medical Center