Exercise as a Treatment for Substance Use Disorders Protocol

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.