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| ID | Type | Description | Link |
|---|---|---|---|
| 1F31AA028696-01A1 | U.S. NIH Grant/Contract | View source | |
| AGR DTD 02-17-2020 | Other Grant/Funding Number | Research Society on Alcoholism | |
| UFCAREDAG002 | Other Grant/Funding Number | UF Center for Addiction Research and Education | |
| 00045887 | Other Grant/Funding Number | UF Dept of Clinical and Health Psychology |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Research Society on Alcohol | OTHER |
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Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Onset Muscle Soreness Induction | Experimental | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps |
|
| Sham Delayed Onset Muscle Soreness Induction | Sham Comparator | Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eccentric Biceps Flexion | Behavioral | Muscle lengthening biceps exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Demand: Breakpoint | Changes in breakpoint of alcohol demand, assessed using the Alcohol Purchase Task. Breakpoint indicates the drink price at which participants report no alcohol consumption. Values represent difference scores derived from breakpoint values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Alcohol Demand: Omax | Changes in Omax, assessed using the Alcohol Purchase Task. Omax reflects the highest total amount in dollars that a participant would spend on alcohol-containing beverages. Values represent difference scores derived from log-transformed Omax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Alcohol Demand: Pmax | Changes in Pmax, assessed using the Alcohol Purchase Task. Pmax reflects the price point at which demand for alcohol becomes elastic (i.e., declines in response to increasing price). Values represent difference scores derived from log-transformed Pmax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Alcohol Demand: Essential Value | Changes in Essential Value, assessed using the Alcohol Purchase Task. Essential Value represents the reinforcing efficacy of alcohol, such that higher Essential Value indicates greater reinforcing efficacy. Values represent difference scores derived from Essential Values coded so that positive numbers indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Cannabis Demand: Intensity | Changes in intensity of cannabis demand, assessed using the Marijuana Purchase Task. Intensity reflects the number of joints that would hypothetically be consumed if they were free. Values represent difference scores derived from log-transformed intensity values coded so that positive values indicate an increase in the demand index from baseline to follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Boissoneault, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Center for Pain Research and Behavioral Health | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed Onset Muscle Soreness Induction | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps Eccentric Biceps Flexion: Muscle lengthening biceps exercise |
| FG001 | Sham Delayed Onset Muscle Soreness Induction | Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps Concentric Biceps Flexion: Muscle shortening biceps exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed Onset Muscle Soreness Induction | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps Eccentric Biceps Flexion: Muscle lengthening biceps exercise |
| BG001 | Sham Delayed Onset Muscle Soreness Induction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Demand: Breakpoint | Changes in breakpoint of alcohol demand, assessed using the Alcohol Purchase Task. Breakpoint indicates the drink price at which participants report no alcohol consumption. Values represent difference scores derived from breakpoint values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | dollars/drink | 48 hours after exercise |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Onset Muscle Soreness Induction | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps Eccentric Biceps Flexion: Muscle lengthening biceps exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Boissoneault, PhD | University of Florida Department of Clinical and Health Psychology | 352-273-6200 | jboissoneault@phhp.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 8, 2022 | Jul 3, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Concentric Biceps Flexion | Behavioral | Muscle shortening biceps exercise |
|
| 48 hours after exercise |
| Cannabis Demand: Breakpoint | Changes in breakpoint of cannabis demand, assessed using the Marijuana Purchase Task. Breakpoint indicates the joint price at which participants report no cannabis consumption. Values represent difference scores derived from breakpoint values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Cannabis Demand: Omax | Changes in Omax, assessed using the Marijuana Purchase Task. Omax reflects the highest total amount that a participant would spend on cannabis. Values represent difference scores derived from log-transformed Omax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Cannabis Demand: Pmax | Changes in Pmax, assessed using the Marijuana Purchase Task. Pmax reflects the price point at which demand for cannabis becomes elastic (i.e., declines in response to increasing price). Values represent difference scores derived from log-transformed Pmax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Cannabis Demand: Essential Value | Changes in Essential Value, assessed using the Marijuana Purchase Task. Essential Value represents the reinforcing efficacy of cannabis, such that higher Essential Value indicates greater reinforcing efficacy. Values represent difference scores derived from Essential Values coded so that positive numbers indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
| Alcohol Demand: Intensity | Changes in intensity of alcohol demand, assessed using the Alcohol Purchase Task. Intensity reflects the number of drinks that would hypothetically be consumed if they were free. Values represent difference scores derived from log-transformed number of drinks coded so that positive values indicate an increase in the demand index from baseline to follow-up. | 48 hours after exercise |
Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps Concentric Biceps Flexion: Muscle shortening biceps exercise |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| PHQ-9 | Patient Health Questionnaire-9 (PHQ-9). Measure of depressive symptomatology over the past 2 weeks. Scores range from 0-27, with higher scores reflecting more severe depression. | Mean | Standard Deviation | units on a scale |
|
| GAD-7 | Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Measures anxiety over the last 2 weeks. Scores range from 0-21, with higher scores reflecting more severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Urge | Visual analog scale (VAS) assessing current urge to consume alcohol, anchored from 'no urge' to 'very strong urge'. Scores range from 0-100, with higher scores reflecting stronger urge. | Mean | Standard Deviation | visual analog scale units |
|
| Cannabis Use Urge | Visual analog scale (VAS) assessing current urge to consume cannabis, anchored from 'no urge' to 'very strong urge'. Scores range from 0-100, with higher scores reflecting stronger urge. | Mean | Standard Deviation | visual analog scale units |
|
| Pain-related Negative Affect | Sum of responses to 0-100 visual analog scales (VASs) assessing current depression, anxiety, frustration, fear, and anger anchored from 'none' to 'worst imaginable'. Total scores range from 0-500, with higher scores reflecting greater pain-related negative affect. | Mean | Standard Deviation | total score |
|
| Negative Urgency | Negative Urgency subscale of the short form of the Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P). Scores are sums of reverse coded responses to items 6, 8, 13, and 15 and range from 0-12, with higher scores reflecting greater negative urgency. | Mean | Standard Deviation | units on UPPS-P subscale |
|
| History of Alcohol Self-Medication | Visual analog scale (VAS) assessing frequency of alcohol use in the past to cope with pain, anchored from 'none of the time' to 'all of the time'. Scores range from 0-100, with higher scores reflecting more frequent self-medication. | Mean | Standard Deviation | visual analog scale units |
|
| History of Cannabis Self-Medication | Visual analog scale (VAS) assessing frequency of cannabis use in the past to cope with pain, anchored from 'none of the time' to 'all of the time'. Scores range from 0-100, with higher scores reflecting more frequent self-medication. | Mean | Standard Deviation | visual analog scale units |
|
| Alcohol Expectancy VAS 1 | Visual analog scale (VAS) assessing belief that using alcohol would provide relief from pain, anchored from 'no pain relief at all' to 'complete pain relief'. Scores range from 0-100, with higher scores reflecting stronger belief that alcohol use will relieve pain. | Mean | Standard Deviation | visual analog scale units |
|
| Alcohol Expectancy VAS 2 | Visual analog scale (VAS) assessing belief that using alcohol would affect pain sensitivity, anchored from 'strongly decreased' to 'strongly increased'. Scores range from 0-100, with higher scores reflecting stronger belief that alcohol use will increase pain sensitivity. | Mean | Standard Deviation | visual analog scale units |
|
| Cannabis Expectancy VAS 1 | Visual analog scale (VAS) assessing belief that using cannabis would provide relief from pain, anchored from 'no pain relief at all' to 'complete pain relief'. Scores range from 0-100, with higher scores reflecting stronger belief that cannabis use will relieve pain. | Mean | Standard Deviation | visual analog scale units |
|
| Cannabis Expectancy VAS 2 | Visual analog scale (VAS) assessing belief that using cannabis would affect pain sensitivity, anchored from 'strongly decreased' to 'strongly increased'. Scores range from 0-100, with higher scores reflecting stronger belief that cannabis use will increase pain sensitivity. | Mean | Standard Deviation | visual analog scale units |
|
| AUDIT Total Score | Total score on the Alcohol Use Disorders Identification Test (AUDIT), which assesses alcohol use disorder symptomatology. Scores range from 0-40, with higher scores indicating more severe symptomatology. | Mean | Standard Deviation | units on a scale |
|
| CUDIT Total Score | Total score on the Cannabis Use Disorders Identification Test (CUDIT), which assesses cannabis use disorder symptomatology. Scores range from 0-40, with higher scores indicating more severe symptomatology. | Mean | Standard Deviation | units on a scale |
|
| ASSIST Cannabis Risk Score | Cannabis risk score derived from the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which assesses substance use-related health risks. Scores range from 0-42, with higher scores indicating higher risk. | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Frequency | Count of Participants | Participants |
|
| Drinks Per Drinking Day | Count of Participants | Participants |
|
| Cannabis Use Frequency | Count of Participants | Participants |
|
| Duration of Cannabis Use at Current Frequency | Count of Participants | Participants |
|
| Primary Method Used to Ingest Cannabis | Count of Participants | Participants |
|
| Primary Form of Cannabis Used | Count of Participants | Participants |
|
| Frequency of Simultaneous Alcohol and Cannabis Use | Visual analog scale (VAS) assessing frequency of simultaneous use of alcohol and cannabis over the past 12 months (such that effects overlapped), anchored from 'not at all' to 'every time'. Scores range from 0-100, with higher scores reflecting more frequent simultaneous use. | Mean | Standard Deviation | visual analog scale units |
|
| Amount Spent on Alcohol in Past Month | Mean | Standard Deviation | dollars |
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| Amount Spent on Cannabis in Past Month | Mean | Standard Deviation | dollars |
|
Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps
Concentric Biceps Flexion: Muscle shortening biceps exercise
| OG002 | Delayed Onset Muscle Soreness Induction (Men) | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps Eccentric Biceps Flexion: Muscle lengthening biceps exercise |
| OG003 | Sham Delayed Onset Muscle Soreness Induction (Men) | Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps Concentric Biceps Flexion: Muscle shortening biceps exercise |
|
|
|
| Primary | Alcohol Demand: Omax | Changes in Omax, assessed using the Alcohol Purchase Task. Omax reflects the highest total amount in dollars that a participant would spend on alcohol-containing beverages. Values represent difference scores derived from log-transformed Omax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | (log)dollars | 48 hours after exercise |
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| Primary | Alcohol Demand: Pmax | Changes in Pmax, assessed using the Alcohol Purchase Task. Pmax reflects the price point at which demand for alcohol becomes elastic (i.e., declines in response to increasing price). Values represent difference scores derived from log-transformed Pmax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | log(dollars/drink) | 48 hours after exercise |
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| Primary | Alcohol Demand: Essential Value | Changes in Essential Value, assessed using the Alcohol Purchase Task. Essential Value represents the reinforcing efficacy of alcohol, such that higher Essential Value indicates greater reinforcing efficacy. Values represent difference scores derived from Essential Values coded so that positive numbers indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | index | 48 hours after exercise |
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| Primary | Cannabis Demand: Intensity | Changes in intensity of cannabis demand, assessed using the Marijuana Purchase Task. Intensity reflects the number of joints that would hypothetically be consumed if they were free. Values represent difference scores derived from log-transformed intensity values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | (log)joints | 48 hours after exercise |
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| Primary | Cannabis Demand: Breakpoint | Changes in breakpoint of cannabis demand, assessed using the Marijuana Purchase Task. Breakpoint indicates the joint price at which participants report no cannabis consumption. Values represent difference scores derived from breakpoint values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | dollars/joint | 48 hours after exercise |
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| Primary | Cannabis Demand: Omax | Changes in Omax, assessed using the Marijuana Purchase Task. Omax reflects the highest total amount that a participant would spend on cannabis. Values represent difference scores derived from log-transformed Omax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | (log)dollars | 48 hours after exercise |
|
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| Primary | Cannabis Demand: Pmax | Changes in Pmax, assessed using the Marijuana Purchase Task. Pmax reflects the price point at which demand for cannabis becomes elastic (i.e., declines in response to increasing price). Values represent difference scores derived from log-transformed Pmax values coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | log(dollars/joint) | 48 hours after exercise |
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| Primary | Cannabis Demand: Essential Value | Changes in Essential Value, assessed using the Marijuana Purchase Task. Essential Value represents the reinforcing efficacy of cannabis, such that higher Essential Value indicates greater reinforcing efficacy. Values represent difference scores derived from Essential Values coded so that positive numbers indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | index | 48 hours after exercise |
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| Primary | Alcohol Demand: Intensity | Changes in intensity of alcohol demand, assessed using the Alcohol Purchase Task. Intensity reflects the number of drinks that would hypothetically be consumed if they were free. Values represent difference scores derived from log-transformed number of drinks coded so that positive values indicate an increase in the demand index from baseline to follow-up. | Posted | Mean | Standard Deviation | log(drinks) | 48 hours after exercise |
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Sham Delayed Onset Muscle Soreness Induction | Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps Concentric Biceps Flexion: Muscle shortening biceps exercise | 0 | 25 | 0 | 25 | 0 | 25 |
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|
2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction. |
| ANCOVA |
F(1,41) = 4.86, partial eta squared = .11 |
| .03 |
| Superiority |
|
2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group. |
| ANCOVA |
| .26 |
| Slope |
| .10 |
| 2-Sided |
| Superiority |
| 2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group. | ANCOVA | .22 | Slope | -.09 | 2-Sided | Superiority |
| 2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group. | ANCOVA | .27 | Slope | -.10 | 2-Sided | Superiority |
| 2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group. | ANCOVA | .49 | Slope | .06 | 2-Sided | Superiority |