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

Primary Purpose

Substance-Related Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

exercise

treatment-as-usual

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

exercise

treatment-as-usual

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in cortisol concentrations

change in endocannabinoid concentrations

Full Information

NCT ID

NCT02570360

First Posted

September 29, 2015

Last Updated

December 13, 2019

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute on Drug Abuse (NIDA), Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT02570360

Brief Title

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

National Institute on Drug Abuse (NIDA), Medical College of Wisconsin

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

exercise

Arm Type

Active Comparator

Arm Description

Arm Title

treatment-as-usual

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

treatment-as-usual

Intervention Description

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

Primary Outcome Measure Information:

Title

Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention

Description

Time Frame

up to 6 weeks

Secondary Outcome Measure Information:

Title

change in cortisol concentrations

Time Frame

measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention

Title

change in endocannabinoid concentrations

Time Frame

measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angelique Brellenthin, MS

Organizational Affiliation

UW-Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53706

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31729933

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.

Results Reference

result

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

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