Exercise as a Treatment for Substance Use Disorders Protocol

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01141608
First received: June 8, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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 Intervention
Stimulant Abuse/Dependence.
Other: Vigorous Intensity High Dose Exercise
Other: Usual Care Augmented with Health Education
Other: Health Education Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Percent Days Abstinent [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    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:
  • Time to relapse (defined as second positive urine test [for stimulants] and use of drugs established by TLFB) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Drug use and related outcomes for all substances (categorized as alcohol, cannabinoids, nicotine, opioids, or sedative/hypnotic/anxiolytics) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to dropout from substance abuse treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Drug use and related outcomes during the entire course of the study (i.e., randomization to 9 months) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Examination of additional health benefits (in sleep, cognitive function, mood, quality of life and anhedonia, and weight gain) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: June 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Vigorous Intensity High Dose Exercise
Usual Care Augmented with Vigorous Intensity High Dose Exercise
Experimental: Health Education Intervention
Usual Care Augmented with Health Education
Other: Usual Care Augmented with Health Education
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: Health Education Intervention
Usual Care Augmented with Health Education

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141608

Locations
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
Investigators
Principal Investigator: Madhukar H Trivedi, M.D. UT Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madhukar H. Trivedi, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01141608     History of Changes
Other Study ID Numbers: 5-U10-DA020024-04S1, 5U10DA020024-05
Study First Received: June 8, 2010
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014