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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04791917
Other study ID # IRB202000058-N
Secondary ID 1F31AA028696-01A
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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