NCT04791917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

March 9, 2021

Results QC Date

March 7, 2023

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

Delayed Onset Muscle Soreness Induction

EXPERIMENTAL

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

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

Behavioral: Concentric Biceps Flexion

Interventions

Muscle lengthening biceps exercise

Delayed Onset Muscle Soreness Induction

Muscle shortening biceps exercise

Sham Delayed Onset Muscle Soreness Induction

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Center for Pain Research and Behavioral Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jeff Boissoneault, PhD
Organization
University of Florida Department of Clinical and Health Psychology

Study Officials

  • Jeff Boissoneault, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 10, 2021

Study Start

October 28, 2020

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

July 27, 2023

Results First Posted

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations