Chronic PainNCT04791917
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
A study testing Eccentric Biceps Flexion and Concentric Biceps Flexion in people with Chronic Pain, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Eccentric Biceps Flexion and Concentric Biceps Flexion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 10 May 2022
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years;
- English-speaking
- Self-identify as White/Caucasian or Black/African American
- Own a smartphone with cellular/data plan
- Regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on item 1 of the CUDIT-R and AUDIT.
- Willing and able to give informed consent
Who cannot join
- Participation in biceps-specific conditioning program in the past 6 months*
- Self-reported wrist/hand, elbow, or shoulder pain the past 3 months
- Chronic medical condition that may affect pain perception (e.g. diabetes, fibromyalgia, headaches)
- Self-reported kidney dysfunction, muscle damage, or major psychiatric disorder
- Medical marijuana prescription
- Consumption of marijuana using only non-inhalational methods (e.g. edibles, tinctures, or cannabidiol oil)
- Score of ≥ 10 on Patient Health Questionnaire-9 (moderate depression)
- Women who are pregnant, trying to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Center for Pain Research and Behavioral Health
Gainesville, Florida, 32610
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Eccentric Biceps Flexion, Concentric Biceps Flexion
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric Biceps FlexionBehavioural
Muscle lengthening biceps exercise
Concentric Biceps FlexionBehavioural
Muscle shortening biceps exercise
| Study group | Role | What they receive |
|---|---|---|
| Delayed Onset Muscle Soreness Induction | Experimental | Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps Receives: Behavioral: Eccentric Biceps Flexion |
| 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 Receives: Behavioral: Concentric Biceps Flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start28 Oct 2020
- Primary completion10 May 2022
- Study completion10 May 2022
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.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Research Society on Alcohol
- Responsible party
- Sponsor
- Investigators
- Jeff Boissoneault, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791917
- Sponsor's protocol ID
- IRB202000058-N
- Other IDs
- 1F31AA028696-01A1, AGR DTD 02-17-2020, UFCAREDAG002, 00045887
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2021
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
- ClinicalTrials.gov ID
- NCT04791917
- Acronym / sponsor ID
- IRB202000058-N
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Research Society on Alcohol
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Onset Muscle Soreness Induction | Experimental | Behavioral: Eccentric Biceps FlexionParticipants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps |
| Sham Delayed Onset Muscle Soreness Induction | Sham comparator | Behavioral: Concentric Biceps FlexionParticipants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 years;
- English-speaking
- Self-identify as White/Caucasian or Black/African American
- Own a smartphone with cellular/data plan
- Regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on item 1 of the CUDIT-R and AUDIT.
Key exclusion criteria (8 listed)
- Participation in biceps-specific conditioning program in the past 6 months*
- Self-reported wrist/hand, elbow, or shoulder pain the past 3 months
- Chronic medical condition that may affect pain perception (e.g. diabetes, fibromyalgia, headaches)
- Self-reported kidney dysfunction, muscle damage, or major psychiatric disorder
- Medical marijuana prescription
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 |
|---|---|---|
| Eccentric Biceps FlexionMuscle lengthening biceps exercise | Behavioural | Delayed Onset Muscle Soreness Induction |
| Concentric Biceps FlexionMuscle shortening biceps exercise | Behavioural | Sham Delayed Onset Muscle Soreness Induction |
Primary outcome
Alcohol Demand: Breakpoint
Time frame: 48 hours after exercise
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.
Alcohol Demand: Omax
Time frame: 48 hours after exercise
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.
Alcohol Demand: Pmax
Time frame: 48 hours after exercise
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.
Alcohol Demand: Essential Value
Time frame: 48 hours after exercise
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.
Cannabis Demand: Intensity
Time frame: 48 hours after exercise
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.
Cannabis Demand: Breakpoint
Time frame: 48 hours after exercise
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.
Cannabis Demand: Omax
Time frame: 48 hours after exercise
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.
Cannabis Demand: Pmax
Time frame: 48 hours after exercise
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.
Cannabis Demand: Essential Value
Time frame: 48 hours after exercise
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.
Alcohol Demand: Intensity
Time frame: 48 hours after exercise
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeff Boissoneault, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Biceps Flexion and Concentric Biceps Flexion in people with Chronic Pain, run by University of Florida 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 8 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 27 Jul 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). 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?
Alcohol Demand: Breakpoint (time frame: 48 hours after exercise). The study lists 10 primary outcomes in all. 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 27 Jul 2023.