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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Colorado
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Denver, Colorado, 미국, 80045
- University of Colorado Anschutz Medical Campus
-
연락하다:
- Ruschelle Leone, PhD
- 전화번호: 303-724-7052
- 이메일: ruschelle.leone@cuanschutz.edu
-
수석 연구원:
- Ruschelle Leone, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
실험적: 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 |
|
실험적: 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. |
|
실험적: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
|
실험적: 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 |
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intervention Likelihood
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 26-1956
- R01AA032801 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD will be available in the NIAAA Data Archive.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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