Exercise as a Treatment for Substance Use Disorders Protocol

NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)

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.

This study is designed as a two-group, randomized controlled trial to test the effectiveness of the addition of exercise and health education to treatment as usual in improving drug treatment outcomes in 330 eligible and interested participants who provide informed consent at 8-10 sites across the nation. These participants will be randomized to one of two treatment arms: (1) Vigorous Intensity High Dose Exercise Augmentation (VIHD): Usual Care Augmented with Vigorous Intensity High Dose Exercise or (2) Health Education Intervention Augmentation (HEI): Usual Care Augmented with Health Education. This study will include individuals diagnosed with stimulant abuse or dependence (cocaine, methamphetamine, amphetamine or other stimulant, except caffeine or nicotine) who begin treatment while in a residential setting.

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-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.