Substance Use Disorders Clinical Trial
Verified date | April 2019 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society
Status | Completed |
Enrollment | 147 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing residential substance use disorders treatment at VA St. Louis Healthcare System - Age 18 or older - English speaking; - Substance dependence - Recent substance use - Does not have high blood pressure - Documented physician clearance to undergo exercise testing & exercise - Plans to begin Aftercare at the clinic within the next two weeks Exclusion Criteria: - Severely disruptive behavior - Serious uncontrolled psychiatric disorder - Medical history in the past 6 months that contraindicates exercise - Pregnancy, plans to get pregnant in the next six months. - Currently breastfeeding - Obese - class II - Currently taking corticosteroids or hormonal contraceptives - In recovery for pathological gambling - Opiate dependence. |
Country | Name | City | State |
---|---|---|---|
United States | VA St. Louis Health Care System - Jefferson Barracks Division | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University | VA St. Louis Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in substance use (relapse) | Relapse is assessed during the duration of the study and is a time to event variable so it will be assess over time. Relapse is defined as drinking alcohol in excess of the National Institute on Alcohol Abuse and Alcohol (NIAAA) at-risk guidelines. | At baseline and every three months for one year. | |
Primary | Change in moderate to vigorous physical activity | Moderate to vigorous physical activity frequency, duration and intensity will be assessed over time to examine changes in response to the intervention. Frequency is defined as how often and individual engages in moderate to vigorous physical activity. Duration is the amount of time (minutes) per episode that individual engages in moderate to vigorous physical activity. Intensity is defined two ways: (1) self-report rating of intensity and (2) metabolic equivalent of the moderate to vigorous physical activity. | At baseline and every three months for one year. | |
Secondary | Change in stress reactivity over time. | Stress reactivity is assess via a standardized psychosocial stressor paradigm that induces stress. Stress is assessed via salivary cortisol and self-report of stress. | At baseline and two additional times over one year. |
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