Exercise as a Treatment for Substance Use Disorders Protocol

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Stimulant Abuse and Dependence

Intervention / Treatment
-----------------
* Other: Vigorous Intensity High Dose Exercise
* Other: Health Education Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigorous Intensity High Dose Exercise<br>Usual Care Augmented with Vigorous Intensity High Dose Exercise | Other: Vigorous Intensity High Dose Exercise<br>* 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.<br>* Other names: Exercise;|
| Experimental: Health Education Intervention<br>Health Education Intervention | Other: Health Education Intervention<br>* 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.<br>* Other names: Exercise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Days Abstinent | 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. | single value calculated based on TLFB data during days 22-84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB) |  | 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) |  | 12 weeks | 
| Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) |  | 12 weeks | 
| Time to Dropout From Substance Abuse Treatment |  | 12 weeks | 
| Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) |  | 9 months | 
| Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) |  | 9 months |