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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Eccentric Biceps Flexion; Behavioral: Concentric Biceps Flexion

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Center for Pain Research and Behavioral Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed Onset Muscle Soreness Induction; Participants will complete an exercise session designed to induce delayed onset muscle soreness in the biceps	Behavioral: Eccentric Biceps Flexion; Muscle lengthening biceps exercise
Sham Comparator: Sham Delayed Onset Muscle Soreness Induction; Participants will complete an exercise session that is unlikely to induce delayed onset muscle soreness in the biceps	Behavioral: Concentric Biceps Flexion; Muscle shortening biceps exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Jeff Boissoneault, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Drinking Behavior; Substance-Related Disorders; Pain; Neurologic Manifestations; Alcohol Drinking; Chronic Pain; Marijuana Use
• Other Study ID Numbers: IRB202000058-N; 1F31AA028696-01A1 (U.S. NIH Grant/Contract); 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No