Exercise as a Treatment for Substance Use Disorders Protocol

NCT ID: NCT01141608

Last Updated: 2020-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stimulant Abuse and Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vigorous Intensity High Dose Exercise

Usual Care Augmented with Vigorous Intensity High Dose Exercise

Group Type EXPERIMENTAL

Vigorous Intensity High Dose Exercise

Intervention Type 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.

Health Education Intervention

Health Education Intervention

Group Type EXPERIMENTAL

Health Education Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Exercise Exercise

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Madhukar H. Trivedi, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhukar H Trivedi, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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Arapahoe House

Denver, Colorado, United States

Site Status

Gateway Community Services

Jacksonville, Florida, United States

Site Status

Gibson Recovery Center, Inc.

Cape Girardeau, Missouri, United States

Site Status

St. Luke's-Roosevelt

New York, New York, United States

Site Status

Penn Presbyterian

Philadelphia, Pennsylvania, United States

Site Status

Charleston VAMC

Charleston, South Carolina, United States

Site Status

Morris Village

Columbia, South Carolina, United States

Site Status

Nexus Recovery, Inc.

Dallas, Texas, United States

Site Status

Memorial Hermann

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34000130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29325238 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28199070 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27693866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21929768 (View on PubMed)

Other Identifiers

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5U10DA020024-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 122009-043

Identifier Type: -

Identifier Source: org_study_id

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