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Completed

NCT Number: NCT02570360

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

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).

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

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

Behavioral

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

Primary outcomes

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

    Time frame: up to 6 weeks

    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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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