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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791917
• Other study ID #: IRB202000058-N
• Secondary ID: 1F31AA028696-01A
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: May 10, 2022

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Chronic Pain
• Marijuana Use

Intervention

Behavioral:
• Eccentric Biceps Flexion
Muscle lengthening biceps exercise
• Concentric Biceps Flexion
Muscle shortening biceps exercise

Locations

Country	Name	City	State
United States	University of Florida Center for Pain Research and Behavioral Health	Gainesville	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Florida	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	48 hours after 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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise
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.	48 hours after exercise