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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570360
• Other study ID #: 2015-0710
• Secondary ID: 1R36DA040140-01A
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• exercise
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.
• treatment-as-usual
The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Medical College of Wisconsin, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. 2019 Nov 15:1-12. doi: 10.1080/08897077.2019.1680480. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in cortisol concentrations		measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention
Secondary	change in endocannabinoid concentrations		measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention