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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
-
Denver、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
-
コンタクト：
- Ruschelle Leone, PhD
- 電話番号：303-724-7052
- メール：ruschelle.leone@cuanschutz.edu
-
主任研究者：
- Ruschelle Leone, PhD
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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 |
|
実験的：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 |
|
実験的：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. |
|
実験的：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
|
実験的：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 |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention Likelihood
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 26-1956
- R01AA032801 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD will be available in the NIAAA Data Archive.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。