Health TrialsbyHealthPanel

Varenicline as a Treatment for Cannabis Use Disorder

ConditionCannabis Abuse
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

DSM-5 diagnosis of cannabis use disorder

Cannabis use ≥ 3 days per week in past 30 days

Ability to read English and provide informed consent

Disqualifiers

Pregnant, breastfeeding, or planning pregnancy

Severe renal impairment (CrCl < 30 mL/min)

Lifetime bipolar I or II disorder, schizophrenia, or other psychotic disorder

Suicidal ideation or behavior within 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Varenicline (Chantix)

    Drug

    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.

  • Placebo

    Drug

    Matched placebo administered daily for 12 weeks.

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: VareniclineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: