Health TrialsbyHealthPanel

Longitudinal Outpatient Treatment for Cannabis Use Disorder

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Colorado, Boulder

About this trial

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Regular use (at least 4 times per week) of cannabis concentrates for at least the last year.

Meets DSM5 criteria for at least moderate CUD.

Currently seeking to cut down or stop cannabis use.

Disqualifiers

Use of any substance of abuse besides alcohol, nicotine, or cannabis (e.g., cocaine, non-prescription use of opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 90 days, as indicated by self-report and urine toxicology screening (Syva Rapid Test) at baseline.

Use of CBD-dominant products in the past 90 days, as evidenced by self-report of use of a CBD>THC product or CBD blood levels at baseline of >= 5 ng/mL

Alcohol use on 3 or more days per week, and/or > 3 drinks per drinking day in the past 90 days. Participants must also have a breath alcohol level of 0 at the beginning of each study visit.

Daily nicotine use.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabidiol - fsCBD

    Drug

    Full-spectrum (i.e., fsCBD, 7.8mg THC (3.4mg BID)), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used.

  • Placebo

    Drug

    Placebo arm

  • Cannabidiol - bsCBD

    Drug

    Broad-spectrum (i.e., bsCBD, 0% THC), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: 400mg Full Spectrum Cannabidiol (fsCBD)Experimental treatment 1 intervention
Group B: 400mg Broad Spectrum Cannabidiol (bsCBD)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in cannabis use

The change in the amount of cannabis used by participants as measured by self-report

Time frame
8 weeks
2

Difference in cannabis use

The change in the amount of cannabis used by participants as measured by biomarkers of metabolites

Time frame
8 weeks
3

Difference in symptoms of cannabis use disorder (CUD)

The change in symptom levels of CUD as measured by the Cannabis Use Disorders Identification Test (CUDIT). This questionnaire was designed for self administration and is scored by adding each of the 8 items: * Question 1-7 are scored on a 0-4 scale * Question 8 is scored 0, 2 or 4. Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.

Time frame
8 weeks
4

Difference in withdrawal symptoms

The change in three facets of withdrawal including affective, physiological, and physical withdrawal symptoms as measured by the Marijuana Withdrawal Checklist (MWC)

Time frame
8 weeks

Secondary outcomes

1

Difference in alcohol use

The change in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)

Time frame
8 weeks
2

Difference in alcohol use

The change in alcohol use as measured by the Timeline Follow-back

Time frame
8 weeks
3

Difference in wellbeing and quality of life

The change in wellbeing as measured by the Health Related Quality of Life survey

Time frame
8 weeks
4

Difference in emotional states

The change in emotional states as measured by the Depression Anxiety and Stress Scale (DASS). Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content (Depression, Anxiety, and Stress). Scores range from 0-42 for each subscale (0-126 for the total scale), with higher numbers reflecting more negative emotional states over the past week.

Time frame
8 weeks

Other outcomes

1

Moderators of designated outcomes

Exploratory models will examine biological sex and age as a moderators of the designated outcomes

Time frame
8 weeks

Sponsors and contacts

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

University of Colorado, Boulder

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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