Substance Use and Media Preferences
The goal of this randomized clinical trial is to learn how alcohol use, cannabis use, and using both substances affect whether and how quickly people stop a video being shown to a woman. The study will recruit 312 people from the Metro-Denver area who drink alcohol and use cannabis; half of the participants will be women. The main questions it aims to answer are:
- How do alcohol, cannabis, and their combined use affect whether participants stop the video and how quickly they do so?
- Does alcohol use versus alcohol and cannabis use by others in the scenario affect whether and how quickly participants stop the video?
Researchers will compare four randomly assigned groups: alcohol only, cannabis only, both alcohol and cannabis, and neither substance. Participants will also be randomly assigned to one of two scenarios involving alcohol use or alcohol and cannabis use by others. These comparisons will help researchers understand how participants' own substance use and substance use by others affect their decisions to intervene.
Participants will:
- Complete a phone call to review the study and schedule a mobile laboratory visit at their home.
- Have their ID checked, complete a breath alcohol test to confirm no alcohol is in their system, and be weighed. Female participants will also take a pregnancy test.
- Provide written consent and complete questionnaires so researchers can confirm eligibility before random assignment.
- Follow their assigned substance-use condition. Participants in the cannabis-only group will smoke their usual cannabis at home while staff monitor them through Zoom. Those in the alcohol-only group will drink two weight-based alcoholic beverages, with a target blood alcohol concentration of 0.08%. Those assigned to both substances will use cannabis first and then drink alcohol. Those assigned to neither substance will not use either as part of the study.
- Provide blood and breath samples to measure cannabis-related THC and alcohol levels.
- Complete a task in which they can choose to stop a video being shown to a woman. Researchers will measure whether they stop the video and how long they take to do so.
- Take part in a recorded interview about their experience and the reasons they did or did not stop the video. Researchers will analyze these interviews to better understand how substance use affects decisions.
- Answer questions about what they believed the study was testing and their impressions of the other participants, receive an explanation of the study, and receive compensation.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80045
- University of Colorado Anschutz Medical Campus
-
Kontakt:
- Ruschelle Leone, PhD
- Telefonnummer: 303-724-7052
- E-post: ruschelle.leone@cuanschutz.edu
-
Huvudutredare:
- Ruschelle Leone, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and lifestyle considerations .
- Aged 21-30, verified by a photo ID.
- Consume an alcohol quantity on a single occasion that is equal to or greater than the dose administered in the laboratory on ≥ 3 days in the past year (see Table 1).
- Smoked cannabis ≥ 3 days in the past year.
- Engaging in simultaneous alcohol and cannabis use ≥ 1 day in the past year.
Exclusion Criteria:
- Currently being treated or in recovery for alcohol or drug problems; currently interested in seeking treatment for drinking or drug use via self-report.
- Experienced an adverse event while co-using alcohol and cannabis at any time in the past 3 months.
- Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration as determined by the Study Physician.
- Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory.
- Self-report that a participant is trying to get pregnant, currently pregnant, or a positive pregnancy test.
- Combined height and weight that is either less than 6 feet tall and over 230 lbs, or over 250 lbs and over 6 ft tall as measured during the lab visit or by a valid photo ID.
- Current or past participation in PI Leone's research study 'Understanding the Influence of Alcohol and Media on Relationships' protocol #24-1867.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Alcohol Consumption + Alcohol Consumption of Others
Participants will be assigned to drink alcohol and the others in the study will also be assigned to drink alcohol. |
Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. Others in the study will be assigned to drink alcohol |
|
Experimentell: Alcohol Consumption + Alcohol/Cannabis Consumption of Others
Participants will be assigned to drink alcohol and the others in the study will be assigned to drink alcohol and consume cannabis. |
Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. Others in the study will be assigned to drink alcohol and consume cannabis |
|
Experimentell: Alcohol/Cannabis Consumption + Alcohol Consumption of Others
Participants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol. |
Others in the study will be assigned to drink alcohol Participants in this group will self-administer legal-market flower cannabis Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. |
|
Experimentell: Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others
Participants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol and consume cannabis. |
Others in the study will be assigned to drink alcohol and consume cannabis Participants in this group will self-administer legal-market flower cannabis Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. |
|
Aktiv komparator: Sober + Alcohol Consumption of Others
Participants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol. |
Others in the study will be assigned to drink alcohol Participants will be assigned to a no-alcohol control beverage and to not consume cannabis. |
|
Aktiv komparator: Sober + Alcohol/Cannabis Consumption of Others
Participants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol and consume cannabis. |
Others in the study will be assigned to drink alcohol and consume cannabis Participants will be assigned to a no-alcohol control beverage and to not consume cannabis. |
|
Experimentell: Cannabis Consumption + Alcohol Consumption of Others
Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol. |
Others in the study will be assigned to drink alcohol Participants in this group will self-administer legal-market flower cannabis |
|
Experimentell: Cannabis Consumption + Alcohol/Cannabis Consumption of Others
Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol and consume cannabis. |
Others in the study will be assigned to drink alcohol and consume cannabis Participants in this group will self-administer legal-market flower cannabis |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intervention Likelihood
Tidsram: Up to three hours after consent
|
Stopping a woman from watching content during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Possible scores are 0 (not stopping) to 1 (stopping). |
Up to three hours after consent
|
|
Intervention Speed
Tidsram: Up to three hours after consent
|
The amount of time the woman watches the sexually explicit film during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Scores range from 0 to 4 minutes. |
Up to three hours after consent
|
|
Number of Bystander Barriers
Tidsram: Up to four hours after consent
|
Count number of barriers experienced during the paradigm via a semi-structured interview. |
Up to four hours after consent
|
|
Number of Bystander Facilitators
Tidsram: Up to four hours after consent
|
Count number of facilitators experienced during the paradigm via a semi-structured interview. |
Up to four hours after consent
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-1956
- R01AA032801 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD will be available in the NIAAA Data Archive.
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