Endocannabinoids in Reward
The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Erin Martin, Ph.D.
- 電話番号：843-876-3528
- メール：marterin@musc.edu
研究場所
-
-
South Carolina
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Charleston、South Carolina、アメリカ、29403
- 募集
- Medical University of South Carolina
-
コンタクト：
- Erin Martin, Ph.D.
- 電話番号：843-876-3528
- メール：marterin@musc.edu
-
-
参加基準
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:
- Able and willing to provide informed consent
- Age 21-45
- Meet DSM-5 criteria for CUD
- Report cannabis use ≥4 days/week on average in the last 30 days at screening
- Provide a THC-positive urine sample at screening
- BMI between 18-30 kg/m2
- Regular menstrual cycle (females only)
- Willing to use non-hormonal birth control for the duration of study participation (females only)
Exclusion Criteria:
- Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
- Urinalysis results indicative of recent drug use other than cannabis
- Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
- Current treatment-seeking for CUD or other SUDs
- Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
- Females who are pregnant, nursing, or planning to become pregnant
- MRI contraindications (e.g., metallic implants, claustrophobia)
- Significant history of nausea associated with the use of cannabis and/or THC
- History of cardiac or seizure disorders
- Allergy to sesame oil
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：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：男性
|
Oral dronabinol capsules (40 mg)
他の名前：
Matched placebo capsules |
|
他の：女性
|
Oral dronabinol capsules (40 mg)
他の名前：
Matched placebo capsules |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nucleus accumbens glutamate
時間枠：2 hours post-dose
|
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy |
2 hours post-dose
|
|
Drug Effects Questionnaire (DEQ) - Like Drug Effect
時間枠：0-7 hours post-dose
|
Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
0-7 hours post-dose
|
|
Sex differences in genetics
時間枠：Day 1
|
Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system |
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dorsal striatal glutamate
時間枠：2 hours post-dose
|
Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy |
2 hours post-dose
|
|
Drug Effects Questionnaire (DEQ) - Want More
時間枠：0-7 hours post-dose
|
Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
0-7 hours post-dose
|
|
Drug Effects Questionnaire (DEQ) - High
時間枠：0-7 hours post-dose
|
Visual Analog Scale rating of subjective "high" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
0-7 hours post-dose
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
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。