THCV Treatment for Smokers
2026年8月3日 更新者：Lara Ray, PhD、University of California, Los Angeles
Development of Tetrahydrocannabivarin as a Treatment for Smokers
This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).
調査の概要
状態
まだ募集していません
詳細な説明
The objective of this study is to examine the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV) in daily smokers.
We will randomize 32 non-treatment-seeking adults who smoke cigarettes daily (50% female) into a randomized, double-blind, placebo-controlled, counter-balanced, within-subject human laboratory study of Δ9-THCV (10 mg oral) and matched placebo.
Specifically, participants will complete two 5-day outpatient medication periods, with a 14-day washout period in between, during which they will receive either Δ9-THCV or placebo in a counter-balanced order, such that all participants will complete both medication conditions across the study.
Following each 5-day medication period, participants will complete a laboratory study visit during which they will undergo the McKee Smoking Lapse Task to assess the ability to resist smoking, cigarette self-administration, craving, withdrawal, and subjective effects of nicotine.
Total study participation will be approximately 4 weeks.
研究の種類
介入
入学 (推定)
32
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jessica Jenkins, MS
- 電話番号：310-206-6756
- メール：jenkinsj@ucla.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Be between the ages of 21 and 65;
- Smoke 10 or more combustible cigarettes per day;
- Have fewer than 3 months of smoking abstinence in the past year;
- Has self-reported ≥10 lifetime uses of cannabis products;
- Have self-reported recent (past 3-month) use of cannabis products;
- Agree to abstain from all other cannabinoid use during the study;
- Agree to abstain from all other medication use during the study, other than methods of birth control as listed in inclusion criteria for female participants;
- Agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile: oral contraceptives, Contraceptive sponge, patch, double barrier, intrauterine contraceptive device, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, hormonal vaginal contraceptive ring, complete abstinence from sexual intercourse.
Exclusion Criteria:
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
- Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
- Have a positive urine screen for any substances, including cannabis
- Have a breathalyzer reading above 0.000 g/dl;
- Be pregnant, nursing, or planning to become pregnant while taking part in the study;
- Have a medical condition that may interfere with safe study participation;
- Have clinically significant abnormalities on the EKG;
- Have evidence of renal impairment, defined by an eGFR value of <90 ml/min;
- Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;
- Exceed Grade 2 laboratory or vital sign abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials";
- Have past month use of cannabis or cannabis products;
- Have past month use of electronic nicotine delivery system (ENDS);
- Have use of any medications (other than methods of birth control as listed in inclusion criteria for female participants) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration, and throughout the study, including medication for smoking cessation, any prescription, OTC, dietary supplements, herbal products, or vitamins;
- Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Δ9-THCV first, then placebo.
Participants will first take a 10mg Δ9-THCV gummy once a day for 5 days.
After a 14-day washout period, participants will take a matched placebo gummy (0mg Δ9-THCV) once a day for 5 days.
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10mg Δ9-Tetrahydrocannabivarin oral gummy
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
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実験的：Placebo first, then THCV
Participants will take a placebo gummy (0mg Δ9-THCV) once a day for 5 days.
After a 14-day washout period, participants will take a 10mg Δ9-THCV gummy once a day for 5 days.
|
10mg Δ9-Tetrahydrocannabivarin oral gummy
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
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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 |
|---|---|---|
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Latency to initiate smoking
時間枠：Assessed during each 5-day medication condition, following overnight abstinence on Day 5
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Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on the ability to resist smoking.
The primary outcome is latency to initiate smoking during the 50-minute delay period, defined as the number of minutes participants delay smoking their first cigarette (range: 0-50 minutes).
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Assessed during each 5-day medication condition, following overnight abstinence on Day 5
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Number of cigarettes smoked during self-administration
時間枠：Assessed during each 5-day medication condition, following overnight abstinence on Day 5
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Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on cigarette self-administration.
The outcome is the number of cigarettes smoked during the 60-minute self-administration period of the task (no set range).
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Assessed during each 5-day medication condition, following overnight abstinence on Day 5
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Questionnaire of Smoking Urges-Brief total score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
|
Participants will complete the 10-item Questionnaire of Smoking Urges-Brief (QSU-Brief) during the McKee Smoking Lapse Task to assess cigarette craving.
The QSU-Brief assesses urges and cravings using a 7-point Likert response scale, with higher scores indicating greater craving (range: 10-70).
Cue-induced cigarette craving in response to cigarette (vs.
neutral) cues will be calculated and compared between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
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Minnesota Nicotine Withdrawal Scale score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
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Participants will complete ratings of nicotine withdrawal following overnight abstinence using the 8-item Minnesota Nicotine Withdrawal Scale (MNWS), with higher values indicating more severe withdrawal (range: 0-32).
Differences in MNWS scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
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Modified Cigarette Evaluation Questionnaire satisfaction score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess satisfaction associated with smoking.
Items are rated on a 7-point scale, with higher scores indicating greater endorsement.
The satisfaction subscale score is calculated as the sum of Items 1, 2, and 12 (range: 3-21).
Differences in satisfaction scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Modified Cigarette Evaluation Questionnaire psychological reward score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess psychological reward associated with smoking.
Items are rated on a 7-point scale, with higher scores indicating greater endorsement.
The psychological reward subscale score is calculated as the sum of Items 4, 5, 6, 7, 8 (range: 5-35).
Differences in psychological reward scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Modified Cigarette Evaluation Questionnaire nausea/dizziness score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess nausea and dizziness associated with smoking.
Items are rated on a 7-point scale, with higher scores indicating greater endorsement.
The nausea/dizziness subscale score is calculated as the sum of Items 9 and 10 (range: 2-14).
Differences in nausea/dizziness scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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Modified Cigarette Evaluation Questionnaire craving relief score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
|
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess craving relief associated with smoking.
Items are rated on a 7-point scale, with higher scores indicating greater endorsement.
The craving relief subscale score is based on Item 11 (range: 1-7).
Differences in craving relief scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
|
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Modified Cigarette Evaluation Questionnaire enjoyment of airway sensations score
時間枠：Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
|
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess the enjoyment of airway sensations associated with smoking.
Items are rated on a 7-point scale, with higher scores indicating greater endorsement.
The enjoyment of airway sensations subscale score is based on Item 3 (range: 1-7).
Differences in enjoyment of airway sensations scores will be evaluated between the Δ9-THCV and placebo conditions.
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Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Lara A Ray, PhD、University of California, Los Angeles
- 主任研究者：Erica N Grodin, PhD、University of California, Los Angeles
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年5月31日
研究の完了 (推定)
2028年5月31日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月4日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年8月1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。