THCV Treatment for Smokers
2026년 8월 3일 업데이트: 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).
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
32
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jessica Jenkins, MS
- 전화번호: 310-206-6756
- 이메일: jenkinsj@ucla.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
10mg Δ9-Tetrahydrocannabivarin oral gummy
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
|
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실험적: 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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Latency to initiate smoking
기간: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
|
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).
|
Assessed during each 5-day medication condition, following overnight abstinence on Day 5
|
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Number of cigarettes smoked during self-administration
기간: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
|
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).
|
Assessed during each 5-day medication condition, following overnight abstinence on Day 5
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Questionnaire of Smoking Urges-Brief total score
기간: 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.
|
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
기간: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
|
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.
|
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
기간: 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 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
기간: 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 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
기간: 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 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
기간: 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.
|
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
기간: 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.
|
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lara A Ray, PhD, University of California, Los Angeles
- 수석 연구원: Erica N Grodin, PhD, University of California, Los Angeles
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2028년 5월 31일
연구 완료 (추정된)
2028년 5월 31일
연구 등록 날짜
최초 제출
2026년 5월 26일
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 3일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB-26-1097
- R21DA059769 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .