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

NCT ID: NCT02570360

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

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

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).

Group Type PLACEBO_COMPARATOR

treatment-as-usual

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

treatment-as-usual

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angelique Brellenthin, MS

Role: PRINCIPAL_INVESTIGATOR

UW-Madison

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 31729933 (View on PubMed)

Other Identifiers

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1R36DA040140-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A176000

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC\KINESIOLOGY\KINESIO

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0710

Identifier Type: -

Identifier Source: org_study_id