Methamphetamine AbuseEarly Phase 1NCT03709667
Exercise in Methamphetamine Use Disorder Upregulation and Neural Function
A Early Phase 1 study testing EX and CON in people with Methamphetamine Abuse, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- EX and CON
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 30 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 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.
- Age 18-65 years
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate to severe stimulant use disorder assessed by MINI.
- 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.
- Labs: hematology and chemistry laboratory test results within normal (+/- 10%) limits.
- Right handed.
Who cannot join
- 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.
- Musculoskeletal disease that would prevent participation in exercise.
- Current psychotic disorder assessed by the MINI.
- Current suicidal ideation/plan, assessed by the Patient Health Questionnaire-9.
- Heart disease: Hypertension or unstable pulmonary or cardiovascular disease that would interfere with participation in the EX regimen
- 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).
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- Pregnancy [Women must provide negative pregnancy urine tests before study entry].
- Asthma or use of theophylline, α- and β-adrenergic agonists, or other sympathomimetics.
- 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.
- 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.
- 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.
- 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.
- Any other condition that would compromise safe participation, determined by the study physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90006
About this study
Official title: Exercise in Methamphetamine Use Disorder: Dopamine Receptor Upregulation and Neural Function
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.
Read the 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.
- Conditions
- Methamphetamine Abuse
- Being tested
- EX, CON
- Keywords
- exercise, methamphetamine
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXBehavioural
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.
CONBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EX | Experimental | Participants in this arm of the study will be randomized in to the exercise intervention. Receives: Behavioral: EX |
| CON | Placebo comparator | The control condition is a health-education intervention. Receives: Behavioral: CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Striatal D2/3 Binding Potential (BPND) Upregulation
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.
Measured: 8 weeks
Secondary outcomes (13)
Sustained attention
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.
Measured: 8 weeks
Working memory
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.
Measured: 8 weeks
Declarative memory
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.
Measured: 8 weeks
Selective attention
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.
Measured: 8 weeks
Inhibitory control - stop signal task
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.
Measured: 8 weeks
Inhibitory control - reversal learning
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.
Measured: 8 weeks
Reward-based decision-making
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.
Measured: 8 weeks
Resting state functional connectivity
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.
Measured: 8 weeks
Task-based brain activity (functional magnetic resonance imaging) - balloon analog risk
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.
Measured: 8 weeks
Task-based brain activity (functional magnetic resonance imaging - stop signal
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.
Measured: 8 weeks
Decision making under risk and ambiguity
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).
Measured: 8 weeks
Loss Aversion
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.
Measured: 8 weeks
Motor Function
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start26 Jun 2019
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Edythe London, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709667
- Sponsor's protocol ID
- 18-000496
- Other IDs
- R01DA045162
- Status last verified
- May 2024
- First submitted
- 12 Jul 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Methamphetamine Use Disorder: Dopamine Receptor Upregulation and Neural Function
- ClinicalTrials.gov ID
- NCT03709667
- Acronym / sponsor ID
- 18-000496
- Conditions
- Methamphetamine Abuse
- Keywords
- exercise, methamphetamine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EX | Experimental | Behavioral: EXParticipants in this arm of the study will be randomized in to the exercise intervention. |
| CON | Placebo comparator | Behavioral: CONThe control condition is a health-education intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Age 18-65 years
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate to severe stimulant use disorder assessed by MINI.
- 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.
- Labs: hematology and chemistry laboratory test results within normal (+/- 10%) limits.
Key exclusion criteria (13 listed)
- 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.
- Musculoskeletal disease that would prevent participation in exercise.
- Current psychotic disorder assessed by the MINI.
- Current suicidal ideation/plan, assessed by the Patient Health Questionnaire-9.
- Heart disease: Hypertension or unstable pulmonary or cardiovascular disease that would interfere with participation in the EX regimen
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 |
|---|---|---|
| EXAn 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. | Behavioural | EX |
| CONParticipants 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. | Behavioural | CON |
Primary outcome
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.
13 secondary outcomes
Sustained attention
Time frame: 8 weeks
Working memory
Time frame: 8 weeks
Declarative memory
Time frame: 8 weeks
Selective attention
Time frame: 8 weeks
Inhibitory control - stop signal task
Time frame: 8 weeks
Inhibitory control - reversal learning
Time frame: 8 weeks
Reward-based decision-making
Time frame: 8 weeks
Resting state functional connectivity
Time frame: 8 weeks
Task-based brain activity (functional magnetic resonance imaging) - balloon analog risk
Time frame: 8 weeks
Task-based brain activity (functional magnetic resonance imaging - stop signal
Time frame: 8 weeks
Decision making under risk and ambiguity
Time frame: 8 weeks
Loss Aversion
Time frame: 8 weeks
Motor Function
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EX and CON in people with Methamphetamine Abuse, run by University of California, Los Angeles at 1 site 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 6 inclusion and 13 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Striatal D2/3 Binding Potential (BPND) Upregulation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.