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Exercise and Treatment-as-usual in Substance Use Treatment Outcomes

Comparative Effects of Exercise and Treatment-as-usual on Abstinence, Craving, and the Endocannabinoid System in Substance Users

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02570360
Enrollment
21
Registered
2015-10-07
Start date
2015-09-30
Completion date
2016-09-30
Last updated
2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-Related Disorders

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).

Interventions

BEHAVIORALexercise

The EX participants will engage in supervised, individual treadmill exercise 3xs/wk at the UW Natatorium. Sessions will consist of a 5-minute warm-up followed by 30 minutes of a moderate to moderately-high intensity exercise and then finish with a 5-minute cool down. Questionnaires will be completed before and after exercise on a weekly basis.

BEHAVIORALtreatment-as-usual

The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Medical College of Wisconsin
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the interventionup to 6 weekswithdrawal 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

MeasureTime frame
change in cortisol concentrationsmeasured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention
change in endocannabinoid concentrationsmeasured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026