Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

THCV Treatment for Smokers

3. august 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Δ9-Tetrahydrocannabivarin (oral gummy)
10mg Δ9-Tetrahydrocannabivarin oral gummy
Legemiddel: Matched Placebo (oral gummy)
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
Eksperimentell: 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.
Legemiddel: Δ9-Tetrahydrocannabivarin (oral gummy)
10mg Δ9-Tetrahydrocannabivarin oral gummy
Legemiddel: Matched Placebo (oral gummy)
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Latency to initiate smoking
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Questionnaire of Smoking Urges-Brief total score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Los Angeles

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. mai 2028

Studiet fullført (Antatt)

31. mai 2028

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-26-1097
  • R21DA059769 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere