Cannabis Use DisorderPhase 2NCT02044809
Cannabidiol: a Novel Intervention for Cannabis Use Problems?
A Phase 2 study testing Cannabidiol in people with Cannabis Use Disorder, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to 5 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 16 and 60 years old.
- Meet DSM-5 criteria for moderate cannabis use disorder (≥4 DSM-5 criteria)
- Express desire to quit using cannabis within the next four weeks,
- Have ≥1 previous failed quit attempt.
- Smoke tobacco with cannabis,
- Test positive for recent cannabis use according to urine analysis,
- Vital signs within healthy limits and have capacity to give consent
Who cannot join
- Not willing to use effective contraception from when consent is taken to 6 weeks after treatment has stopped
- Positive pregnancy test or breastfeeding
- Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients
- >twice/month use of other illicit drugs
- Outside normal Body Mass Index (BMI)
- A physical health problem deemed clinically significant
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- The use of current prescribed psychotropic drugs
- Current or prior self-reported diagnosis of a psychotic disorder
- Non-English speakers due to verbal assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa/b, Randomised, Double-blind, Placebo-controlled, Single-site, Parallel Group Clinical Trial to Examine Cannabidiol (CBD) as a Pharmacological Treatment for Cannabis Dependence.
The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.
- Conditions
- Cannabis Use Disorder
- Being tested
- Cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cannabidiol 200mg Oral | Experimental | Not described Receives: Drug: Cannabidiol |
| Cannabidiol 400mg Oral | Experimental | Not described Receives: Drug: Cannabidiol |
| Cannabidiol 800mg Oral | Experimental | Not described Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)
This study has two stages. This is the primary endpoint criteria for stage 1.
Measured: up to 4 weeks
Number of days abstinent from cannabis
This study has two stages. This is the primary endpoint criteria for stage 1.
Measured: up to 4 weeks
Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence
This study has two stages. This is the primary endpoint criteria for stage 2.
Measured: up to 4 weeks
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml
This study has two stages. This is the primary endpoint criteria for stage 2.
Measured: week 4
Secondary outcomes (1)
Psychological Wellbeing, Cognition and Endocannabinoids
Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion9 Feb 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044809
- Sponsor's protocol ID
- 12/0278
- Status last verified
- Oct 2018
- First submitted
- 22 Jan 2014
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lees R, Hines LA, Hindocha C, Baio G, Shaban NDC, Stothart G, Mofeez A, Morgan CJA, Curran HV, Freeman TP. Effect of four-week cannabidiol treatment on cognitive function: secondary outcomes from a randomised clinical trial for the treatment of cannabis use disorder. Psychopharmacology (Berl). 2023 Feb;240(2):337-346. doi: 10.1007/s00213-022-06303-5. Epub 2023 Jan 4.
PubMed 36598543Freeman TP, Hindocha C, Baio G, Shaban NDC, Thomas EM, Astbury D, Freeman AM, Lees R, Craft S, Morrison PD, Bloomfield MAP, O'Ryan D, Kinghorn J, Morgan CJA, Mofeez A, Curran HV. Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial. Lancet Psychiatry. 2020 Oct;7(10):865-874. doi: 10.1016/S2215-0366(20)30290-X. Epub 2020 Jul 28.
PubMed 32735782
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa/b, Randomised, Double-blind, Placebo-controlled, Single-site, Parallel Group Clinical Trial to Examine Cannabidiol (CBD) as a Pharmacological Treatment for Cannabis Dependence.
- ClinicalTrials.gov ID
- NCT02044809
- Acronym / sponsor ID
- 12/0278
- Conditions
- Cannabis Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cannabidiol 200mg Oral | Experimental | Drug: Cannabidiol |
| Cannabidiol 400mg Oral | Experimental | Drug: Cannabidiol |
| Cannabidiol 800mg Oral | Experimental | Drug: Cannabidiol |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged between 16 and 60 years old.
- Meet DSM-5 criteria for moderate cannabis use disorder (≥4 DSM-5 criteria)
- Express desire to quit using cannabis within the next four weeks,
- Have ≥1 previous failed quit attempt.
- Smoke tobacco with cannabis,
Key exclusion criteria (9 listed)
- Not willing to use effective contraception from when consent is taken to 6 weeks after treatment has stopped
- Positive pregnancy test or breastfeeding
- Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients
- >twice/month use of other illicit drugs
- Outside normal Body Mass Index (BMI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol | Drug | Cannabidiol 200mg Oral, Cannabidiol 400mg Oral, Cannabidiol 800mg Oral |
| Placebo | Drug | Placebo |
Primary outcome
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)
Time frame: up to 4 weeks
This study has two stages. This is the primary endpoint criteria for stage 1.
Number of days abstinent from cannabis
Time frame: up to 4 weeks
This study has two stages. This is the primary endpoint criteria for stage 1.
Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence
Time frame: up to 4 weeks
This study has two stages. This is the primary endpoint criteria for stage 2.
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml
Time frame: week 4
This study has two stages. This is the primary endpoint criteria for stage 2.
1 secondary outcome
Psychological Wellbeing, Cognition and Endocannabinoids
Time frame: Up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Derived from this study: PubMed 36598543Lees R, Hines LA, Hindocha C, Baio G, Shaban NDC, Stothart G, Mofeez A, Morgan CJA, Curran HV, Freeman TP. Effect of four-week cannabidiol treatment on cognitive function: secondary outcomes from a randomised clinical trial for the treatment of cannabis use disorder. Psychopharmacology (Berl). 2023 Feb;240(2):337-346. doi: 10.1007/s00213-022-06303-5. Epub 2023 Jan 4.
- Derived from this study: PubMed 32735782Freeman TP, Hindocha C, Baio G, Shaban NDC, Thomas EM, Astbury D, Freeman AM, Lees R, Craft S, Morrison PD, Bloomfield MAP, O'Ryan D, Kinghorn J, Morgan CJA, Mofeez A, Curran HV. Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial. Lancet Psychiatry. 2020 Oct;7(10):865-874. doi: 10.1016/S2215-0366(20)30290-X. Epub 2020 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Cannabis Use Disorder, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine) (time frame: up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044809, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.