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Exercise in Methamphetamine Use Disorder Upregulation and Neural Function

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ClinicalTrials.gov Identifier: NCT03709667
Recruitment Status : Enrolling by invitation
First Posted : October 17, 2018
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Edythe London, University of California, Los Angeles

Brief Summary:
The purpose of this research study is to determine the effects of an exercise intervention and health-education program on brain dopamine receptors and on cognitive functions that have been linked to these receptors.

Condition or disease Intervention/treatment Phase
Methamphetamine Abuse Behavioral: EX Behavioral: CON Early Phase 1

Detailed Description:
After completing baseline assessments within 2 wks after admission, participants will be randomized to one of two interventions: Exercise (EX, active intervention), consisting of 3x-weekly 50-min aerobic + resistance-training sessions for 8 wk; Health Education (control intervention, CON), consisting of 50-min health education sessions 3x-weekly for 8 wk. Participants will undergo positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) scans while performing the stop signal task (SST) and the reversal learning task (RLT) (cognitive computer tasks) at baseline and after completing the 8-wk protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise in Methamphetamine Use Disorder: Dopamine Receptor Upregulation and Neural Function
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EX
Participants in this arm of the study will be randomized in to the exercise intervention.
Behavioral: EX
An individualized aerobic and resistance-exercise program will be developed for each participant on the basis of a maximal incremental exercise test and strength assessments performed at baseline. This test will measure aerobic capacity (VO2 max) and the metabolic or lactate threshold (VO2θ) (i.e., the level of O2 uptake that defines one's ability to perform prolonged work), using indirect calorimetry with an automated metabolic-measurement system. The intervention will comprise 24 sessions over 8 wk (3x/wk), supervised by a credentialed exercise specialist. Each session will consist of a 5-min warm-up, 30-40 min of aerobic activity on a treadmill, 15-20 min of resistance training, and a 5-min cool-down.

Placebo Comparator: CON
The control condition is a health-education intervention.
Behavioral: CON
Participants attend 50-min sessions 3x/wk matched to EX for staff contact. A counselor will facilitate integrative group discussions, and will conduct a multimedia program addressing various health, wellness and lifestyle topics, such as nutrition, dental care, stress relief, sleep hygiene, relationships, immunizations, health screening, smoking, environmental health, and time management.




Primary Outcome Measures :
  1. Striatal D2/3 Binding Potential (BPND) Upregulation [ Time Frame: 8 weeks ]
    Dopamine D2-type receptor binding potential in the striatum measured with positron emission tomography scanning measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.


Secondary Outcome Measures :
  1. Sustained attention [ Time Frame: 8 weeks ]

    The Continuous Performance Task will be used to assess sustained attention at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The following outcome variables will be assessed:

    Correct Detection: Number of responses to the target stimulus. Reaction times: Length of time between stimulus presentation and response. Omission errors: Number of target presentations with no response. Commission errors: Number of responses without target stimulus presentation.

    High omission rates reflect impaired attention, higher correct detections reflect improved attention.


  2. Working memory [ Time Frame: 8 weeks ]
    The Sternberg Spatial Task will be used to assess working memory at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The number of correct responses will be measured, with higher amounts of correct responses reflecting better working memory.

  3. Declarative memory [ Time Frame: 8 weeks ]
    The Rey Auditory Verbal Learning Test will be used to assess declarative memory at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The number of words correctly recalled will be recorded before and after a 20 minute delay, as well as the number of intrusions. The corresponding Z score and percentile of each participant's responses will be calculated.

  4. Selective attention [ Time Frame: 8 weeks ]
    The Stroop Task will be used to assess working memory at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The number of words, colors, and number of color words within a set time will be measured, as well as the number of errors. Larger amounts of errors reflect worse selective attention, whereas higher numbers of words, colors, and number of color words completed reflect better selective attention.

  5. Inhibitory control - stop signal task [ Time Frame: 8 weeks ]
    The Stop-signal task will be used to assess inhibitory control at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  6. Inhibitory control - reversal learning [ Time Frame: 8 weeks ]
    A reversal learning task will be used to assess inhibitory control at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  7. Reward-based decision-making [ Time Frame: 8 weeks ]
    A monetary delay-discounting task/questionnaires and the Balloon Analogue Risk task will be used to assess reward-based decision-making at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The primary outcome measures include the number of balloon pumps and earnings, with more pumps and earnings reflecting greater risk.

  8. Resting state functional connectivity [ Time Frame: 8 weeks ]
    Striatum resting state functional connectivity will be measured with a functional magnetic resonance imaging scan at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  9. Task-based brain activity (functional magnetic resonance imaging) - balloon analog risk [ Time Frame: 8 weeks ]
    Performance on a cognitive task (the Balloon Analog Risk Task) will be assessed during a functional magnetic resonance imaging scan at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  10. Task-based brain activity (functional magnetic resonance imaging - stop signal [ Time Frame: 8 weeks ]
    Performance on a cognitive task the (Stop Signal Task), will be assessed during a functional magnetic resonance imaging scan at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  11. Decision making under risk and ambiguity [ Time Frame: 8 weeks ]
    A task involving decision making under during differing types of risk and ambiguity will be used to determine decision making under risk and ambiguity at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The Risk and Ambiguity Task measures tolerance for risk under conditions of known risk (alpha) and unknown risk (beta).

  12. Loss Aversion [ Time Frame: 8 weeks ]
    A computer task and written questionnaire assessing loss preferences will be used to assess loss aversion at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment.

  13. Motor Function [ Time Frame: 8 weeks ]
    A finger tapping test will be to assess motor function at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment. The number of finger taps in 10 seconds will be recorded three times per hand, and averaged to create the primary outcome measure reflecting motor function.


Other Outcome Measures:
  1. Personality - impulsivity [ Time Frame: 8 weeks ]
    Self-report of impulsivity will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment with the Barratt Impulsiveness Scale (11). The total score will be calculated as measured at both time points as the primary outcome measure.

  2. Personality - novelty seeking [ Time Frame: Baseline ]
    Self-report of novelty seeking will be measured at baseline prior to the EX or CON intervention using the Temperament and Character Inventory.

  3. Personality - reward dependence [ Time Frame: Baseline ]
    Self-report of reward dependence will be measured at baseline prior to the EX or CON intervention using the Temperament and Character Inventory.

  4. Methamphetamine Craving [ Time Frame: 8 weeks ]
    Self-report of craving of methamphetamine will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Brief Meth Craving Scale. A total summary score is calculated and used as the primary outcome measure.

  5. Cocaine Craving [ Time Frame: 8 weeks ]
    Self-report of craving of cocaine will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Cocaine Craving Questionnaire-Brief. A total summary score is calculated and used as the primary outcome measure.

  6. Personality- risk taking [ Time Frame: 8 weeks ]
    Self-report of risk perceptions and risk behaviors will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Domain Specific Risk Taking Scale. Three scores will be computed: Risk Taking, Risk Perception, and Expected Benefits and changes in these scores will be measured at both time points.

  7. Stimulant Withdrawal Score [ Time Frame: 8 weeks ]
    Self-report of withdrawal symptoms from stimulants will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Amphetamine Cessation Symptom Assessment. This 15 item questionnaire assesses acute (within the past 24 hours) craving, with lower scores reflecting lower craving. Changes in the total score will be assessed.

  8. Smoking Withdrawal Score [ Time Frame: 8 weeks ]
    Self-report of withdrawal symptoms from tobacco will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Shiffman-Jarvik Withdrawal Scale on each scan day. This scale consists of 25 items assessing acute withdrawal, with lower scores reflecting lower withdrawal. Changes in the total score will be assessed.

  9. Sleep Quality Rating [ Time Frame: 8 weeks ]
    Self-report of sleep quality symptoms will be measured at baseline prior to exercise (EX) and after 8 weeks of EX (vs. CON) treatment using the Pittsburgh Sleep Quality Inventory. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.

  10. State and trait anxiety [ Time Frame: 8 weeks ]
    Self-report of anxiety symptoms will be measured at baseline prior to exercise (EX) and weekly during the 8 weeks of EX (vs. CON) treatment using the Speilberger State-Trait Anxiety Inventory.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Language: Participants must be fluent in English, as demonstrated by verbal skills sufficient to participate in a conversation, including the ability to ask and answer questions at a level that assures adequate understanding of the study. A comprehension quiz will be administered.
  2. Age 18-65 years
  3. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate to severe stimulant use disorder assessed by MINI.
  4. Vital Signs: Within the clinically acceptable normal range (e.g., resting pulse 50 to 99/min, blood pressure between 85-150 mm Hg systolic and 45-90 mm Hg diastolic.
  5. Labs: hematology and chemistry laboratory test results within normal (+/- 10%) limits.
  6. Right handed.

Exclusion Criteria:

  1. Neurological disease: history of seizure disorder, brain injury with loss of consciousness > 30 min, or other neurological disorder that would interfere with informed consent, data interpretation or participant safety.
  2. Musculoskeletal disease that would prevent participation in exercise.
  3. Current psychotic disorder assessed by the MINI.
  4. Current suicidal ideation/plan, assessed by the Patient Health Questionnaire-9.
  5. Heart disease: Hypertension or unstable pulmonary or cardiovascular disease that would interfere with participation in the EX regimen
  6. Evidence of untreated or unstable medical illness, including endocrine, autoimmune, renal, hepatic, or active infectious disease, which might compromise safe participation (HIV+ participants must be receiving a stable regimen of antiretroviral medication throughout the course of the study).
  7. Pregnancy [Women must provide negative pregnancy urine tests before study entry].
  8. Asthma or use of theophylline, α- and β-adrenergic agonists, or other sympathomimetics.
  9. Medications: Antihypertensive agents, antidepressants, and antiretroviral medications are prescribed to some clients at Cri-Help. Any participant taking any medication that has direct dopaminergic action (e.g., bupropion, neuroleptics) will be excluded, but other chronic medications such as selective serotonin reuptake inhibitors will be allowed. Any participant taking a medication chronically must maintain a stable dose throughout the study; antiretrovirals and antidepressants must be initiated at least 1 week before baseline scan.
  10. Radiation Exposure: Participants who have participated in any other research study involving exposure to ionizing radiation in the past year if the total cumulative dose from the past research studies and the current research study would exceed the limits described by the FDA in 21 Code of Federal Regulations 361.1. Specifically, the total annual cumulative dose to the body, active blood-forming organs, lens of the eye and gonads must remain below 5 rems and the total annual cumulative dose to all other organs must remain below 15 rems. Potential participants who have had exposure to ionizing radiation in the past year cannot be allowed to participate if the investigators are unable to obtain proper documentation quantifying the amount of past exposure.
  11. Metal devices: (e.g., pacemaker, infusion pump, aneurysm clip, prosthesis, plate) in the body.Presence of such a device could interfere with scan acquisition or pose a potential risk during MRI. [A participant who has an implanted device can enroll with documentation that the device is MRI-compatible.
  12. Claustrophobia: Subjects will be questioned about their potential discomfort with enclosed spaces, such as an MRI scanner. Subjects reporting problems with enclosed spaces will be excluded.
  13. Any other condition that would compromise safe participation, determined by the study physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709667


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90006
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Edythe London, Professor of Psychiatry and Biobehavioral Sciences and Molecular and Medical Pharmacology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03709667    
Other Study ID Numbers: 18-000496
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edythe London, University of California, Los Angeles:
exercise
methamphetamine