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

NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)

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.

Study Overview

• Status: Completed
• Conditions: Stimulant Abuse and Dependence
• Intervention / Treatment: Other: Vigorous Intensity High Dose Exercise; Other: Health Education Intervention

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 Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80236
      • Arapahoe House
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Gateway Community Services
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Gibson Recovery Center, Inc.
  • New York
    • New York, New York, United States, 10019
      • St. Luke's-Roosevelt
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Charleston VAMC
    • Columbia, South Carolina, United States, 29203
      • Morris Village
  • Texas
    • Dallas, Texas, United States, 75228
      • Nexus Recovery, Inc.
    • Houston, Texas, United States, 77080
      • Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Exercise
Experimental: 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 Names: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Days Abstinent	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.	single value calculated based on TLFB data during days 22-84

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Jha MK, Schatzberg A, Minhajuddin A, Chin Fatt C, Mayes TL, Trivedi MH. Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project. J Clin Psychiatry. 2021 Apr 13;82(3). pii: 20m13740. doi: 10.4088/JCP.20m13740.
• Trombello JM, Killian MO, Liao A, Sanchez K, Greer TL, Walker R, Grannemann B, Rethorst CD, Carmody T, Trivedi MH. Psychometrics of the Self-Report Concise Associated Symptoms Tracking Scale (CAST-SR): Results From the STRIDE (CTN-0037) Study. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11707. doi: 10.4088/JCP.17m11707.
• Trivedi MH, Greer TL, Rethorst CD, Carmody T, Grannemann BD, Walker R, Warden D, Shores-Wilson K, Stoutenberg M, Oden N, Silverstein M, Hodgkins C, Love L, Seamans C, Stotts A, Causey T, Szucs-Reed RP, Rinaldi P, Myrick H, Straus M, Liu D, Lindblad R, Church T, Blair SN, Nunes EV. Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study. J Clin Psychiatry. 2017 Sep/Oct;78(8):1075-1082. doi: 10.4088/JCP.15m10591.
• Warden D, Sanchez K, Greer T, Carmody T, Walker R, Dela Cruz A, Toups M, Rethorst C, Trivedi MH. Demographic and clinical characteristics of current comorbid psychiatric disorders in a randomized clinical trial for adults with stimulant use disorders. Psychiatry Res. 2016 Dec 30;246:136-141. doi: 10.1016/j.psychres.2016.09.007. Epub 2016 Sep 15.
• Trivedi MH, Greer TL, Grannemann BD, Church TS, Somoza E, Blair SN, Szapocznik J, Stoutenberg M, Rethorst C, Warden D, Ring KM, Walker R, Morris DW, Kosinski AS, Kyle T, Marcus B, Crowell B, Oden N, Nunes E. Stimulant reduction intervention using dosed exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial. Trials. 2011 Sep 19;12:206. doi: 10.1186/1745-6215-12-206.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STU 122009-043; 5U10DA020024-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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."
• IPD Sharing Time Frame: 18 months following study completion.
• IPD Sharing Supporting Information Type: Study Protocol