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THCV Treatment for Smokers

maanantai 3. elokuuta 2026 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

32

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Jessica Jenkins, MS
  • Puhelinnumero: 310-206-6756
  • Sähköposti: jenkinsj@ucla.edu

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Inclusion Criteria:

  1. Be between the ages of 21 and 65;
  2. Smoke 10 or more combustible cigarettes per day;
  3. Have fewer than 3 months of smoking abstinence in the past year;
  4. Has self-reported ≥10 lifetime uses of cannabis products;
  5. Have self-reported recent (past 3-month) use of cannabis products;
  6. Agree to abstain from all other cannabinoid use during the study;
  7. 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;
  8. 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:

  1. Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
  2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
  3. Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
  4. Have a positive urine screen for any substances, including cannabis
  5. Have a breathalyzer reading above 0.000 g/dl;
  6. Be pregnant, nursing, or planning to become pregnant while taking part in the study;
  7. Have a medical condition that may interfere with safe study participation;
  8. Have clinically significant abnormalities on the EKG;
  9. Have evidence of renal impairment, defined by an eGFR value of <90 ml/min;
  10. Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;
  11. 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";
  12. Have past month use of cannabis or cannabis products;
  13. Have past month use of electronic nicotine delivery system (ENDS);
  14. 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;
  15. Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Crossover-tehtävä
  • Naamiointi: Kolminkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Lääke: Δ9-Tetrahydrocannabivarin (oral gummy)
10mg Δ9-Tetrahydrocannabivarin oral gummy
Lääke: Matched Placebo (oral gummy)
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
Kokeellinen: 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.
Lääke: Δ9-Tetrahydrocannabivarin (oral gummy)
10mg Δ9-Tetrahydrocannabivarin oral gummy
Lääke: Matched Placebo (oral gummy)
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Latency to initiate smoking
Aikaikkuna: 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
Number of cigarettes smoked during self-administration
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Questionnaire of Smoking Urges-Brief total score
Aikaikkuna: 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
Minnesota Nicotine Withdrawal Scale score
Aikaikkuna: 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
Modified Cigarette Evaluation Questionnaire satisfaction score
Aikaikkuna: 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.
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire psychological reward score
Aikaikkuna: 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.
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire nausea/dizziness score
Aikaikkuna: 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.
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire craving relief score
Aikaikkuna: 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.
Modified Cigarette Evaluation Questionnaire enjoyment of airway sensations score
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of California, Los Angeles

Yhteistyökumppanit

National Institute on Drug Abuse (NIDA)

Tutkijat

  • Päätutkija: Lara A Ray, PhD, University of California, Los Angeles
  • Päätutkija: Erica N Grodin, PhD, University of California, Los Angeles

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Muut tutkimustunnusnumerot

  • IRB-26-1097
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