N/A
N=302
Exercise as a Treatment for Substance Use Disorders Protocol
Stimulant Abuse and Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01141608 ↗Enrolled (actual)
302
Serious AEs
13.3%
Results posted
Sep 2018
Primary outcome: Primary: Percent Days Abstinent — 90.8; 91.6; 75.5; 77.2 Percentage of Days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vigorous Intensity High Dose Exercise (Other); Health Education Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Days Abstinent |
90.8; 91.6; 75.5; 77.2 | <0.05 sig |
| SECONDARY Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB) |
— | — |
| SECONDARY Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief) |
— | — |
| SECONDARY Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) |
— | — |
| SECONDARY Time to Dropout From Substance Abuse Treatment |
— | — |
| SECONDARY Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) |
— | — |
| SECONDARY Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) |
— | — |
Summary
The purpose of this study is to investigate if health interventions (intensive exercise or health education) can be used to help improve substance abuse treatment. The primary objective of this protocol is to compare percent days of abstinence between Vigorous Intensity High Dose exercise (VIHD) and Health Education Intervention (HEI) groups based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during a 12-week acute phase.
Eligibility Criteria
Inclusion Criteria
- Male or female age 18-65.
- Admitted to residential setting and receiving substance use treatment.
- Ability to understand and willingness to provide written informed consent.
- Agree to remain in facility for authorized treatment of about 21-30 days.
- Willing to provide contact information.
- Self-reported use of stimulant drug (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the 30 days prior to admission for treatment.
- Meets DSM-IV criteria for substance abuse or dependence for stimulants (cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) within the last 12 months.
- Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
- Body mass index (BMI)≤40 kg/m2 or BMI 40 >kg/m2 and cleared by medical personnel to exercise.
- Able to comprehend and communicate in English.
Exclusion Criteria
- Evidence of general medical condition or other abnormality that contraindicates use of exercise, based on the Medical Screening Visit.
- Current opiate dependence.
- Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
- Pregnancy.
- Significant physical activity, defined as aerobic exercise more than 3 times per week for 20 minutes or more, completed consistently for the three months prior to study enrollment.
- Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
- Concomitant treatments: beta blockers; methadone, buprenorphine, or any other opioid replacement therapies.
Data sourced from ClinicalTrials.gov (NCT01141608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.