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
4 other identifiers
interventional
21
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedDecember 18, 2019
December 1, 2019
1 year
September 29, 2015
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention
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.
up to 6 weeks
Secondary Outcomes (2)
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
Study Arms (2)
exercise
ACTIVE COMPARATORParticipants 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.
treatment-as-usual
PLACEBO COMPARATORParticipants 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).
Interventions
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.
The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Institute on Drug Abuse (NIDA)collaborator
- Medical College of Wisconsincollaborator
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Related Publications (1)
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.
PMID: 31729933RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angelique Brellenthin, MS
UW-Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 7, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
December 18, 2019
Record last verified: 2019-12