Clinical trial NCT02570360: Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
Official title: Comparative Effects of Exercise and Treatment-as-usual on Abstinence, Craving, and the Endocannabinoid System in Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Medical College of Wisconsin
First posted: 2015-10-07
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
timeFrame: up to 6 weeks
Secondary outcomes:
measure: change in cortisol concentrations
timeFrame: measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention
measure: change in endocannabinoid concentrations
timeFrame: measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: UW-Madison
name: Angelique Brellenthin, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brellenthin AG, Crombie KM, Hillard CJ, Brown RT, Koltyn KF. Psychological and endocannabinoid responses to aerobic exercise in substance use disorder patients. Subst Abus. 2021;42(3):272-283. doi: 10.1080/08897077.2019.1680480. Epub 2019 Nov 15.