Exercise as a Treatment for Substance Use Disorders Protocol

NCT01141608 | Completed Results DMC

• 2 other identifiers: STU 122009-0435U10DA020024-05
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 9

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.

Conditions

Stimulant Abuse and Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Vigorous Intensity High Dose Exercise

EXPERIMENTAL

Usual Care Augmented with Vigorous Intensity High Dose Exercise

Other: Vigorous Intensity High Dose Exercise

Health Education Intervention

EXPERIMENTAL

Health Education Intervention

Other: Health Education Intervention

Interventions

Vigorous Intensity High Dose Exercise OTHER

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.

Also known as: Exercise

Vigorous Intensity High Dose Exercise

Health Education Intervention OTHER

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.

Also known as: Exercise

Health Education Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Arapahoe House

Denver, Colorado, 80236, United States

Location

Gateway Community Services

Jacksonville, Florida, 32204, United States

Location

Gibson Recovery Center, Inc.

Cape Girardeau, Missouri, 63703, United States

Location

St. Luke's-Roosevelt

New York, New York, 10019, United States

Location

Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Charleston VAMC

Charleston, South Carolina, 29401, United States

Location

Morris Village

Columbia, South Carolina, 29203, United States

Location

Nexus Recovery, Inc.

Dallas, Texas, 75228, United States

Location

Memorial Hermann

Houston, Texas, 77080, United States

Location

Related Publications (5)

• 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):20m13740. doi: 10.4088/JCP.20m13740.

  PMID: 34000130 DERIVED

• 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.

  PMID: 29325238 DERIVED

• 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.

  PMID: 28199070 DERIVED

• 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.

  PMID: 27693866 DERIVED

• 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.

  PMID: 21929768 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Enrollment of less severe group and differential adherence rates in the treatment arms are limitations.

Results Point of Contact

• Title: Dr. Madhukar H Trivedi
• Organization: UT Southwestern Medical Center

madhukar.trivedi@utsouthwestern.edu

214-648-0188

Study Officials

• Madhukar H Trivedi, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 3, 2020
• Results First Posted: September 11, 2018

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 18 months following study completion.

Locations

US (9)