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Exercise as a Treatment for Substance Use Disorders Protocol (STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01141608
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : September 11, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stimulant Abuse and Dependence Other: Vigorous Intensity High Dose Exercise Other: Health Education Intervention Not Applicable

Detailed Description:
This study is designed as a two-group, randomized controlled trial to test the effectiveness of the addition of exercise and health education to treatment as usual in improving drug treatment outcomes in 330 eligible and interested participants who provide informed consent at 8-10 sites across the nation. These participants will be randomized to one of two treatment arms: (1) Vigorous Intensity High Dose Exercise Augmentation (VIHD): Usual Care Augmented with Vigorous Intensity High Dose Exercise or (2) Health Education Intervention Augmentation (HEI): Usual Care Augmented with Health Education. This study will include individuals diagnosed with stimulant abuse or dependence (cocaine, methamphetamine, amphetamine or other stimulant, except caffeine or nicotine) who begin treatment while in a residential setting.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)
Actual Study Start Date : June 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vigorous Intensity High Dose Exercise
Usual Care Augmented with Vigorous Intensity High Dose Exercise
 Other: Vigorous Intensity High Dose Exercise
Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.
Other Name: Exercise
Experimental: Health Education Intervention
Health Education Intervention
 Other: Health Education Intervention
Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
Other Name: Exercise


Outcome Measures
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Primary Outcome Measures :
  1. Percent Days Abstinent [ Time Frame: single value calculated based on TLFB data during days 22-84 ]
    Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week.


Secondary Outcome Measures :
  1. Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB) [ Time Frame: 12 weeks ]
  2. Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief) [ Time Frame: 12 weeks ]
  3. Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) [ Time Frame: 12 weeks ]
  4. Time to Dropout From Substance Abuse Treatment [ Time Frame: 12 weeks ]
  5. Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) [ Time Frame: 9 months ]
  6. Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141608


Locations
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United States, Colorado
Arapahoe House
Denver, Colorado, United States, 80236
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32204
United States, Missouri
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, United States, 63703
United States, New York
St. Luke's-Roosevelt
New York, New York, United States, 10019
United States, Pennsylvania
Penn Presbyterian
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston VAMC
Charleston, South Carolina, United States, 29401
Morris Village
Columbia, South Carolina, United States, 29203
United States, Texas
Nexus Recovery, Inc.
Dallas, Texas, United States, 75228
Memorial Hermann
Houston, Texas, United States, 77080
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Madhukar H Trivedi, M.D. UT Southwestern Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Madhukar H. Trivedi, MD, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01141608    
Other Study ID Numbers: STU 122009-043
5U10DA020024-05 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2010    Key Record Dates
Results First Posted: September 11, 2018
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "Per CTN policy, study data is shared within 18-months of study completion. Data that has been shared has been completely de-identified to prevent linkages to individual research participants. This includes removal of all Personal Health Information (PHI) and indirect identifiers that are not listed as PHI but could lead to 'deductive disclosure' such as comment fields and site numbers."
Supporting Materials: Study Protocol
Time Frame: 18 months following study completion.
URL: https://datashare.nida.nih.gov/