Exercise as a Treatment for Substance Use Disorders Protocol

Completed · Not applicable

Conditions studied: Stimulant Abuse and Dependence

In brief

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.

Key facts

Study ID

NCT01141608

Run by

University of Texas Southwestern Medical Center

People needed

302

Starts

2010-06-01

Expected to finish

2013-02-01

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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