Comparative Effects of Exercise and Treatment-as-usual on Abstinence, Craving, and the Endocannabinoid System in Substance Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
Study Overview
Brief Summary
The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a rolling admissions format over the course of a year, approximately 36 treatment-seeking substance users who are currently receiving Intensive Outpatient Treatment through a local Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic exercise training in addition to standard care or standard care with 6 weekly laboratory visits to complete questionnaires (18 per group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Intact cognitive status and ability to provide informed consent
- •ability to read and write in English sufficient to provide consent and complete study questionnaires
- •current diagnosis of a single or of multiple substance use disorders
- •currently enrolled in an Intensive Outpatient Treatment substance use program
- •desire to quit and to seek treatment for substance use
- •currently sedentary, not participating in any formal/structured exercise program
Exclusion Criteria
- •a history or present diagnosis of severe depression, psychotic, or bipolar disorder
- •presence of cardiac disease or any other medical condition that would make engaging in exercise unsafe
- •Undergoing methadone treatment
- •chronic conditions such as cancer, diabetes, kidney disease, or autoimmune disorders
- •women who are pregnant or planning to become pregnant
Arms & Interventions
exercise
Participants will engage in their outpatient treatment program as-usual, but additionally complete 30mins of moderately intense aerobic exercise 3 times per week for 6 weeks. They will complete 6 weeks of treatment, totaling 18 sessions with exercise.
Intervention: exercise (Behavioral)
treatment-as-usual
Participants will engage in their outpatient treatment program as-usual,but additionally complete 6 weekly, hour-long visits to complete questionnaires. They will complete 6 weeks of treatment (6 sessions total).
Intervention: treatment-as-usual (Behavioral)
Outcomes
Primary Outcomes
Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
Time Frame: up to 6 weeks
withdrawal symptoms will be assessed using the Withdrawal Checklist which asks participants to rate the severity of a variety physical and psychological symptoms over the past 48 hours. The total score on the Withdrawal Checklist will be used to provide an overall measured of withdrawal.
Secondary Outcomes
- change in cortisol concentrations(measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention)
- change in endocannabinoid concentrations(measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention)