Development of Tetrahydrocannabivarin as a Treatment for Smokers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Matched Placebo (oral gummy) (Drug)
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.
干预措施: Δ9-Tetrahydrocannabivarin (oral gummy) (Drug)
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.
干预措施: Matched Placebo (oral gummy) (Drug)
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.
干预措施: Δ9-Tetrahydrocannabivarin (oral gummy) (Drug)
研究者
Lara Ray, PhD
Professor
University of California, Los Angeles