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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA045162 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EX | Experimental | Participants in this arm of the study will be randomized in to the exercise intervention. |
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| CON | Placebo Comparator | The control condition is a health-education intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EX | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Personality - impulsivity | 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. | 8 weeks |
| Personality - novelty seeking |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90006 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 6, 2024 | |
| Reset | Dec 30, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2022 | May 6, 2022 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2024 | Dec 30, 2024 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| CON | Behavioral | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 8 weeks |
Self-report of novelty seeking will be measured at baseline prior to the EX or CON intervention using the Temperament and Character Inventory. |
| Baseline |
| Personality - reward dependence | Self-report of reward dependence will be measured at baseline prior to the EX or CON intervention using the Temperament and Character Inventory. | Baseline |
| Methamphetamine Craving | 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. | 8 weeks |
| Cocaine Craving | 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. | 8 weeks |
| Personality- risk taking | 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. | 8 weeks |
| Stimulant Withdrawal Score | 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 weeks |
| Smoking Withdrawal Score | 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. | 8 weeks |
| Sleep Quality Rating | 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. | 8 weeks |
| State and trait anxiety | 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. | 8 weeks |