Stimulant Abuse and DependenceSTRIDENCT01141608
Exercise as a Treatment for Substance Use Disorders Protocol
A study testing Vigorous Intensity High Dose Exercise and Health Education Intervention in people with Stimulant Abuse and Dependence, run by University of Texas Southwestern Medical Center at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stimulant Abuse and Dependence
- What is being tested?
- Vigorous Intensity High Dose Exercise and Health Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, 63703
Charleston VAMC
Charleston, South Carolina, 29401
Morris Village
Columbia, South Carolina, 29203
Nexus Recovery, Inc.
Dallas, Texas, 75228
Arapahoe House
Denver, Colorado, 80236
Memorial Hermann
Houston, Texas, 77080
Gateway Community Services
Jacksonville, Florida, 32204
St. Luke's-Roosevelt
New York, New York, 10019
Penn Presbyterian
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Stimulant Abuse and Dependence
- Being tested
- Vigorous Intensity High Dose Exercise, Health Education Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous Intensity High Dose ExerciseOther
Also called 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 InterventionOther
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Vigorous Intensity High Dose Exercise | Experimental | Usual Care Augmented with Vigorous Intensity High Dose Exercise Receives: Other: Vigorous Intensity High Dose Exercise |
| Health Education Intervention | Experimental | Health Education Intervention Receives: Other: Health Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 12 weeks
Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)
Measured: 12 weeks
Time to Dropout From Substance Abuse Treatment
Measured: 12 weeks
Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)
Measured: 9 months
Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stimulant Abuse and DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H Trivedi, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141608
- Sponsor's protocol ID
- STU 122009-043
- Other IDs
- 5U10DA020024-05
- Acronym
- STRIDE
- Status last verified
- Sep 2020
- First submitted
- 8 Jun 2010
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: "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."
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):20m13740. doi: 10.4088/JCP.20m13740.
PubMed 34000130Trombello 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.
PubMed 29325238Trivedi 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.
PubMed 28199070Warden 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.
PubMed 27693866Trivedi 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.
PubMed 21929768
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDA CTN Protocol 0037: Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)
- ClinicalTrials.gov ID
- NCT01141608
- Acronym / sponsor ID
- STRIDE / STU 122009-043
- Conditions
- Stimulant Abuse and Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2010 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigorous Intensity High Dose Exercise | Experimental | Other: Vigorous Intensity High Dose ExerciseUsual Care Augmented with Vigorous Intensity High Dose Exercise |
| Health Education Intervention | Experimental | Other: Health Education InterventionHealth Education Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigorous Intensity High Dose ExerciseAlso: ExerciseParticipants 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 |
| Health Education InterventionAlso: ExerciseParticipants 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 |
Primary outcome
Percent Days Abstinent
Time frame: 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.
6 secondary outcomes
Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB)
Time frame: 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)
Time frame: 12 weeks
Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)
Time frame: 12 weeks
Time to Dropout From Substance Abuse Treatment
Time frame: 12 weeks
Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)
Time frame: 9 months
Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34000130Jha 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.
- Derived from this study: PubMed 29325238Trombello 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.
- Derived from this study: PubMed 28199070Trivedi 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.
- Derived from this study: PubMed 27693866Warden 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.
- Derived from this study: PubMed 21929768Trivedi 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.
- Individual participant dataSharing planned: Yes. "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."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H Trivedi, M.D. principal investigator
University of Texas Southwestern Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigorous Intensity High Dose Exercise and Health Education Intervention in people with Stimulant Abuse and Dependence, run by University of Texas Southwestern Medical Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Days Abstinent (time frame: single value calculated based on TLFB data during days 22-84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141608, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.