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Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Biceps Flexion
Concentric Biceps Flexion
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Florida Center for Pain Research and Behavioral Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Delayed Onset Muscle Soreness Induction

Sham Delayed Onset Muscle Soreness Induction

Arm Description

Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps

Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2021
Last Updated
July 5, 2023
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Research Society on Alcoholism, University of Florida Center for Addiction Research and Education, University of Florida Department of Clinical and Health Psychology
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1. Study Identification

Unique Protocol Identification Number
NCT04791917
Brief Title
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Official Title
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Research Society on Alcoholism, University of Florida Center for Addiction Research and Education, University of Florida Department of Clinical and Health Psychology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Onset Muscle Soreness Induction
Arm Type
Experimental
Arm Description
Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps
Arm Title
Sham Delayed Onset Muscle Soreness Induction
Arm Type
Sham Comparator
Arm Description
Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps
Intervention Type
Behavioral
Intervention Name(s)
Eccentric Biceps Flexion
Intervention Description
Muscle lengthening biceps exercise
Intervention Type
Behavioral
Intervention Name(s)
Concentric Biceps Flexion
Intervention Description
Muscle shortening biceps exercise
Primary Outcome Measure Information:
Title
Alcohol Demand: Breakpoint
Description
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.
Time Frame
48 hours after exercise
Title
Alcohol Demand: Omax
Description
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.
Time Frame
48 hours after exercise
Title
Alcohol Demand: Pmax
Description
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.
Time Frame
48 hours after exercise
Title
Alcohol Demand: Essential Value
Description
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.
Time Frame
48 hours after exercise
Title
Cannabis Demand: Intensity
Description
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.
Time Frame
48 hours after exercise
Title
Cannabis Demand: Breakpoint
Description
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.
Time Frame
48 hours after exercise
Title
Cannabis Demand: Omax
Description
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.
Time Frame
48 hours after exercise
Title
Cannabis Demand: Pmax
Description
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.
Time Frame
48 hours after exercise
Title
Cannabis Demand: Essential Value
Description
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.
Time Frame
48 hours after exercise
Title
Alcohol Demand: Intensity
Description
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.
Time Frame
48 hours after exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Boissoneault, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Center for Pain Research and Behavioral Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study

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