STRIDE: Exercise as a Treatment for Substance Use Disorders Protocol

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01141608
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 302
• Locations: 9
• Arms: 2
• Actual Duration (Months): 32.1
• Patients Per Site: 33.6
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jun 1, 2010
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

1. Percent Days Abstinent [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) [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) [12 weeks]

3. Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics) [12 weeks]

4. Time to Dropout From Substance Abuse Treatment [12 weeks]

5. Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months) [9 months]

6. Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain) [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Arapahoe House	Denver	Colorado	United States	80236
2	Gateway Community Services	Jacksonville	Florida	United States	32204
3	Gibson Recovery Center, Inc.	Cape Girardeau	Missouri	United States	63703
4	St. Luke's-Roosevelt	New York	New York	United States	10019
5	Penn Presbyterian	Philadelphia	Pennsylvania	United States	19104
6	Charleston VAMC	Charleston	South Carolina	United States	29401
7	Morris Village	Columbia	South Carolina	United States	29203
8	Nexus Recovery, Inc.	Dallas	Texas	United States	75228
9	Memorial Hermann	Houston	Texas	United States	77080

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Madhukar H Trivedi, M.D., UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• First Posted: Jun 10, 2010
• Last Update Posted: Sep 3, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

Participant Flow

Arm/Group Title	Vigorous Intensity High Dose Exercise	Health Education Intervention
Arm/Group Description	Usual Care Augmented with Vigorous Intensity High Dose Exercise 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.	Health Education Intervention 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.
Period Title: Overall Study
STARTED	152	150
COMPLETED	152	150
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Vigorous Intensity High Dose Exercise	Health Education Intervention	Total
Arm/Group Description	Usual Care Augmented with Vigorous Intensity High Dose Exercise 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.	Health Education Intervention 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.	Total of all reporting groups
Overall Participants	152	150	302
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	152 100%	150 100%	302 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.5 (10)	39.5 (11)	39 (10.5)
Sex: Female, Male (Count of Participants)
Female	63 41.4%	58 38.7%	121 40.1%
Male	89 58.6%	92 61.3%	181 59.9%
Region of Enrollment (Count of Participants)
United States	152 100%	150 100%	302 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Mean percent stimulant abstinence days based on Timeline Follow back and Eliminate Contradiction (ELCON) algorithm adjustment.

Arm/Group Title	Vigorous Intensity High Dose Exercise	Health Education Intervention
Arm/Group Description	Participants randomized to Exercise completed supervised exercise sessions 3 times per week during the 12-week acute phase. Exercise was prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% of maximal heart rate (HRmax).	Participants randomized to Health Education also completed 3 visits per week during the 12-week acute phase. Health Education consisted of one-on-one sessions in which information on health-related topics (e.g., cancer, heart disease, mental health) was distributed via didactics, websites, audio, video, and written materials.
Measure Participants	152	150
Timeline Follow Back (TLFB)	90.8 (16.4)	91.6 (14.7)
ELCON algorithm	75.5 (27.4)	77.2 (25.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vigorous Intensity High Dose Exercise, Health Education Intervention
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Linear mixed effects model
	Comments

2. Secondary Outcome

Title	Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Time to Dropout From Substance Abuse Treatment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Vigorous Intensity High Dose Exercise		Health Education Intervention
Arm/Group Description	Usual Care Augmented with Vigorous Intensity High Dose Exercise 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.		Health Education Intervention 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.
All Cause Mortality
	Vigorous Intensity High Dose Exercise		Health Education Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vigorous Intensity High Dose Exercise		Health Education Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/152 (12.5%)		21/150 (14%)
Surgical and medical procedures
Medical condition	19/152 (12.5%)	26	21/150 (14%)	24
Other (Not Including Serious) Adverse Events
	Vigorous Intensity High Dose Exercise		Health Education Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/152 (52%)		28/150 (18.7%)
Blood and lymphatic system disorders
Febrile Neutropenia	0/152 (0%)	0	1/150 (0.7%)	1
Cardiac disorders
Arrythmia	2/152 (1.3%)	2	0/150 (0%)	0
Ear and labyrinth disorders
Hearing impaired	1/152 (0.7%)	1	0/150 (0%)	0
Gastrointestinal disorders
Abdominal pain lower	1/152 (0.7%)	1	0/150 (0%)	0
Gastric ulcer haemorrhage	1/152 (0.7%)	1	0/150 (0%)	0
Gastrointestinal haemorrhage	1/152 (0.7%)	1	0/150 (0%)	0
Inguinal hernia	1/152 (0.7%)	1	0/150 (0%)	0
Nausea	1/152 (0.7%)	1	0/150 (0%)	0
Pancreatitis	1/152 (0.7%)	1	0/150 (0%)	0
General disorders
chest discomfort	3/152 (2%)	3	0/150 (0%)	0
chest pain	3/152 (2%)	3	1/150 (0.7%)	1
Fatigue	2/152 (1.3%)	2	0/150 (0%)	0
Non-cardiac chest apin	0/152 (0%)	0	1/150 (0.7%)	1
oedema peripheral	1/152 (0.7%)	1	0/150 (0%)	0
Hepatobiliary disorders
Cholelithiasis	1/152 (0.7%)	1	0/150 (0%)	0
Infections and infestations
Abcess	0/152 (0%)	0	1/150 (0.7%)	1
Brochitis	0/152 (0%)	0	1/150 (0.7%)	1
Cellulitis	0/152 (0%)	0	1/150 (0.7%)	1
Diverticulus	1/152 (0.7%)	1	0/150 (0%)	0
Gastroenteritis	1/152 (0.7%)	1	0/150 (0%)	0
Gastroenteritis cryptosporidial	0/152 (0%)	0	1/150 (0.7%)	1
Hepatitis C	1/152 (0.7%)	1	0/150 (0%)	0
Influenza	0/152 (0%)	0	1/150 (0.7%)	1
Kidney infection	2/152 (1.3%)	2	0/150 (0%)	0
Pneumonia	0/152 (0%)	0	1/150 (0.7%)	1
Tooth abcess	0/152 (0%)	0	1/150 (0.7%)	1
Injury, poisoning and procedural complications
Accidental overdose	0/152 (0%)	0	1/150 (0.7%)	1
Concussion	1/152 (0.7%)	1	0/150 (0%)	0
Craniocerebral injury	1/152 (0.7%)	1	0/150 (0%)	0
Hand fracture	1/152 (0.7%)	1	1/150 (0.7%)	1
Heat exhaustion	1/152 (0.7%)	1	0/150 (0%)	0
Heat Stroke	0/152 (0%)	0	1/150 (0.7%)	1
Laceration	1/152 (0.7%)	1	0/150 (0%)	0
Ligament rupture	1/152 (0.7%)	1	0/150 (0%)	0
Ligament Sprain	0/152 (0%)	0	1/150 (0.7%)	1
Muscle strain	2/152 (1.3%)	2	0/150 (0%)	0
Post lumbar puncture syndrome	1/152 (0.7%)	1	0/150 (0%)	0
Road Traffic accident	1/152 (0.7%)	1	0/150 (0%)	0
Subdural haematoma	1/152 (0.7%)	1	0/150 (0%)	0
Toxicity to various agents	0/152 (0%)	0	1/150 (0.7%)	1
Wrist fracture	0/152 (0%)	0	1/150 (0.7%)	1
Investigations
Blood iron decreased	1/152 (0.7%)	1	0/150 (0%)	0
Blood pressure abnormal	0/152 (0%)	0	1/150 (0.7%)	1
Blood pressure diastolic decreased	1/152 (0.7%)	1	0/150 (0%)	0
Blood pressure diastolic increased	1/152 (0.7%)	1	0/150 (0%)	0
Metabolism and nutrition disorders
Hyperglycemia	0/152 (0%)	0	1/150 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	17/152 (11.2%)	17	1/150 (0.7%)	1
Back pain	10/152 (6.6%)	10	0/150 (0%)	0
Joint crepitation	1/152 (0.7%)	1	0/150 (0%)	0
Joint swelling	1/152 (0.7%)	1	0/150 (0%)	0
Medial tibial stress syndrome	2/152 (1.3%)	2	0/150 (0%)	0
Muscle spasms	8/152 (5.3%)	8	0/150 (0%)	0
Muscle tightness	3/152 (2%)	3	0/150 (0%)	0
Musculo skeleton pain	1/152 (0.7%)	1	0/150 (0%)	0
Myalgia	11/152 (7.2%)	11	0/150 (0%)	0
Pain in extremity	13/152 (8.6%)	13	0/150 (0%)	0
Nervous system disorders
Burning sensation	1/152 (0.7%)	1	0/150 (0%)	0
Dizziness	8/152 (5.3%)	8	0/150 (0%)	0
Headache	0/152 (0%)	0	1/150 (0.7%)	1
Hypoaesthesia	1/152 (0.7%)	1	0/150 (0%)	0
Intracranial aneurysm	0/152 (0%)	0	1/150 (0.7%)	1
Migraine	1/152 (0.7%)	1	0/150 (0%)	0
Paraesthesia	1/152 (0.7%)	1	0/150 (0%)	0
Sciatica	1/152 (0.7%)	1	0/150 (0%)	0
Psychiatric disorders
Abnormal behaviour	0/152 (0%)	0	1/150 (0.7%)	1
Alcohol abuse	0/152 (0%)	0	1/150 (0.7%)	1
depression	2/152 (1.3%)	2	0/150 (0%)	0
Depression suicidal	0/152 (0%)	0	1/150 (0.7%)	1
Mental Status Changes	0/152 (0%)	0	1/150 (0.7%)	1
Post Traumatic stress Disorder	0/152 (0%)	0	1/150 (0.7%)	1
Suicidal Behavior	1/152 (0.7%)	1	0/150 (0%)	0
Suicidal Ideation	4/152 (2.6%)	4	3/150 (2%)	3
Suicide Attempt	1/152 (0.7%)	1	3/150 (2%)	3
Respiratory, thoracic and mediastinal disorders
Asthma	3/152 (2%)	3	0/150 (0%)	0
Dyspnoea	2/152 (1.3%)	2	1/150 (0.7%)	1
Pulmonary Embolism	1/152 (0.7%)	1	0/150 (0%)	0
Skin and subcutaneous tissue disorders
Blister	2/152 (1.3%)	2	0/150 (0%)	0
skin irritation	1/152 (0.7%)	1	0/150 (0%)	0
Victim of homicide	1/152 (0.7%)	1	0/150 (0%)	0
Social circumstances
Victim of Crime	1/152 (0.7%)	1	0/150 (0%)	0
victim of sexual abuse	1/152 (0.7%)	1	0/150 (0%)	0
Surgical and medical procedures
Sinus Operation	0/152 (0%)	0	1/150 (0.7%)	1
Vascular disorders
Hypertension	0/152 (0%)	0	1/150 (0.7%)	1
Hypertensive crisis	0/152 (0%)	0	1/150 (0.7%)	1

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.