ClinicalTrials.gg
Not yet recruitingNCT07783555Updated Aug 25, 2026

Varenicline as a Treatment for Cannabis Use Disorder

A Phase 2 interventional study of Varenicline (Chantix) and Placebo in Cannabis Abuse, sponsored by Medical University of South Carolina. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Primary conditionMarijuana Abuse(the registry's first term)UnverifiedIs this wrong?The registry often attaches Marijuana Abuse to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Marijuana is the most commonly used illicit drug, and there is a high demand for effective treatments for cannabis use disorder, yet few specific pharmacological treatments have been developed. This study will evaluate the efficacy and safety of varenicline for reducing marijuana use in adults who use marijuana frequently. Participants will be randomized to receive either varenicline or placebo for 12 weeks, along with computerized cognitive behavioral therapy. Cannabis use, medication adherence, and safety outcomes will be assessed throughout treatment and at a follow-up visit.

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Conditions studied

  • Cannabis Abuse

Browse trials for

03

In context

Marijuana Abuse Unverified

188 studies on the registry are indexed under Marijuana Abuse; 26 are open to participants now.

This study's planned enrollment of 224 is above the median of 51 across 160 interventional studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Compared within Marijuana Abuse, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • diagnosis of cannabis use disorder
  • Cannabis use ≥ 3 days per week in past 30 days
  • Ability to read English and provide
  • Willingness to comply with medication and study procedures
  • Agreement to use acceptable if of

Exclusion criteria

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning pregnancy
  • Severe renal impairment ( \< 30 mL/min)
  • Lifetime bipolar I or II disorder, schizophrenia, or other psychotic disorder
  • Suicidal ideation or behavior within 6 months
  • Use of excluded psychotropic medications (e.g., bupropion, nortriptyline)
  • Moderate or severe non-cannabis substance use disorder (except nicotine)
  • cardiovascular or cerebrovascular disease in past 6 months
  • to varenicline
  • Participation in another drug study within 30 days
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
224 participants (estimated)

Study arms

  • Active comparator
    Varenicline

    Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period.

    Drug: Varenicline (Chantix)

  • Placebo comparator
    Placebo

    Matched placebo administered daily for 12 weeks.

    Drug: Placebo

Interventions

  • Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period.

  • DrugPlacebo

    Matched placebo administered daily for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Cannabis use reduction

    The primary efficacy outcome is cannabis use reduction as measured by daily substance use logs and examined as the total number of use sessions at each weekly visit.

    Time frame: Weeks 6-12

  2. Group equivalence

    There will equivalence of the average number of weekly use sessions reported between men and women.

    Time frame: Weeks 6-12

  3. Treatment responder classification

    Determine what baseline demographic, cannabis use, and clinical characteristics best differentiate positive study treatment responders as compared to non-responders .

    Time frame: Weeks 6-12

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Nov 2031, 59 months later.

Of 11 phase 2 interventional studies under Marijuana Abuse, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 42. This study's planned 59 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 25, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Nov 30, 2031
CompletionEst.
Nov 30, 2031
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07783555
Responsible party
Aimee McRae-Clark (Professor-Faculty, Medical University of South Carolina) — Principal investigator
First posted
Aug 25, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2031 (estimated)
Completion
Nov 30, 2031 (estimated)
Last update
Aug 25, 2026

Study contacts

Lisa Program Manager, MS
Contact
jenkinli@musc.edu
843-792-0476

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Varenicline

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