Smoking, MarijuanaPhase 2NCT01844687

Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

A Phase 2 study testing CBD in people with Smoking, Marijuana, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Smoking, Marijuana
What is being tested?: CBD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: May 2013to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Who cannot join

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Center for Drug and Alcohol Programs, Room 459 North, 67 President St.
Charleston, South Carolina, 29425
University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
Lexington, Kentucky, 40513
Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
New York, New York, 10032

Other trials in United States

About this study

Official title: Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana

The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

Read the detailed description

Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC. Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically produced cannabidiol is given to healthy marijuana users in this study to test its capability to reduce the high of THC and, thereby, help to relieve addiction to marijuana.

Conditions: Smoking, Marijuana
Being tested: CBD
Keywords: reinforcement, good drug effect, high, mood, cannabidiol
Medical subject headings: Marijuana Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBDDrug
Also called cannabidiol is abbreviated CBD
Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.

Study groups in NCT01844687
Study group	Role	What they receive
Active marijuana (MJ) with 0 mg CBD	Other	Active MJ cigarettes contain 5.30% THC Receives: Drug: CBD
Active MJ with 200 mg CBD	Other	Active MJ cigarettes contain 5.30% THC Receives: Drug: CBD
Active MJ with 400 mg CBD	Other	Active MJ cigarettes contain 5.30% THC Receives: Drug: CBD
Active MJ with 800 mg CBD	Other	Active MJ cigarettes contain 5.30% THC Receives: Drug: CBD
Inactive MJ with 0 mg CBD	Other	Inactive MJ cigarettes contain 0.01% THC Receives: Drug: CBD
Inactive MJ with 200 mg CBD	Other	Inactive MJ cigarettes contain 0.01% THC Receives: Drug: CBD
Inactive MJ with 400 mg CBD	Other	Inactive MJ cigarettes contain 0.01% THC Receives: Drug: CBD
Inactive MJ with 800 mg CBD	Other	Inactive MJ cigarettes contain 0.01% THC Receives: Drug: CBD

What is being measured

The primary outcome is the main question the study is designed to answer.

Mood Scale - Subscale 'Feeling High'
Participants rated how much they felt having a "high" feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely).
Measured: two hours before and after marijuana cigarette smoking

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Oct 2014

First posted1 May 2013 (estimated)
Study startMay 2013
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking, MarijuanaStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01844687
Sponsor's protocol ID: Study Number CBD-001
Status last verified: Apr 2017
First submitted: 29 Apr 2013
Last updated: 9 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking, Marijuana trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
ClinicalTrials.gov ID: NCT01844687
Acronym / sponsor ID: Study Number CBD-001
Conditions: Smoking, Marijuana
Keywords: reinforcement, good drug effect, high, mood, cannabidiol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: National Institute on Drug Abuse (NIDA)US National Institutes of Health
Study start: May 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 1 May 2013 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Active marijuana (MJ) with 0 mg CBD	Other	Drug: CBDActive MJ cigarettes contain 5.30% THC
Active MJ with 200 mg CBD	Other	Drug: CBDActive MJ cigarettes contain 5.30% THC
Active MJ with 400 mg CBD	Other	Drug: CBDActive MJ cigarettes contain 5.30% THC
Active MJ with 800 mg CBD	Other	Drug: CBDActive MJ cigarettes contain 5.30% THC
Inactive MJ with 0 mg CBD	Other	Drug: CBDInactive MJ cigarettes contain 0.01% THC
Inactive MJ with 200 mg CBD	Other	Drug: CBDInactive MJ cigarettes contain 0.01% THC
Inactive MJ with 400 mg CBD	Other	Drug: CBDInactive MJ cigarettes contain 0.01% THC
Inactive MJ with 800 mg CBD	Other	Drug: CBDInactive MJ cigarettes contain 0.01% THC

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Key exclusion criteria (8 listed)

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment

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
CBDAlso: cannabidiol is abbreviated CBDEach subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.	Drug	Active MJ with 200 mg CBD, Active MJ with 400 mg CBD, Active MJ with 800 mg CBD, Active marijuana (MJ) with 0 mg CBD, Inactive MJ with 0 mg CBD, Inactive MJ with 200 mg CBD, Inactive MJ with 400 mg CBD, Inactive MJ with 800 mg CBD

Primary outcome

Mood Scale - Subscale 'Feeling High'
Time frame: two hours before and after marijuana cigarette smoking
Participants rated how much they felt having a "high" feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely).

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Group	50	42

Primary outcome: Mood Scale - Subscale 'Feeling High'

Time frame: two hours before and after marijuana cigarette smoking. Mean (Standard Error). Unit: units on a scale VAS 1-100 mm

Measure	Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) n = 31	Active MJ With 200 mg CBD n = 31	Active MJ With 400 mg CBD n = 31	Active MJ With 800 mg CBD n = 31	Inactive MJ With 0 mg CBD n = 31	Inactive MJ With 200 mg CBD n = 31	Inactive MJ With 400 mg CBD n = 31	Inactive MJ With 800 mg CBD n = 31
-120 mins	4.35 (2.61)	2.48 (1.24)	0.39 (0.18)	6.55 (2.69)	0.42 (0.26)	0.32 (0.19)	3.35 (2.01)	1.06 (0.79)
-30 mins	4.39 (2.22)	3.13 (1.75)	4.32 (1.83)	2.10 (1.06)	1.94 (1.37)	2.00 (1.87)	1.00 (0.68)	2.87 (1.87)
30 mins after MJ	46.65 (5.69)	45.90 (5.11)	43.32 (5.22)	36.65 (5.37)	10.52 (2.88)	17.84 (4.24)	6.23 (1.56)	13.94 (3.87)
60 mins after MJ	36.55 (5.42)	38.03 (4.72)	32.68 (4.79)	43.10 (5.54)	7.23 (2.73)	8.84 (3.08)	4.03 (1.83)	6.94 (2.54)
90 mins after MJ	24.29 (5.26)	26.87 (4.28)	15.39 (3.64)	24.90 (4.39)	4.71 (2.25)	8.39 (2.77)	2.10 (1.09)	2.48 (1.27)
120 mins after MJ	17.19 (4.60)	17.13 (3.64)	11.65 (3.04)	16.84 (3.89)	2.35 (1.47)	4.48 (1.82)	0.68 (0.33)	4.26 (2.35)

Population analysed: all 31 completers

Adverse events

Time frame: Adverse events reported within 72 hours of each cannabidiol administration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active MJ With 0 mg CBD	0 of 50 (0%)	5 of 50 (10%)	0 of 50
Active MJ With 200 mg CBD	0 of 50 (0%)	8 of 50 (16%)	0 of 50
Active MJ With 400 mg CBD	0 of 50 (0%)	4 of 50 (8%)	0 of 50
Active MJ With 800 mg CBD	0 of 50 (0%)	3 of 50 (6%)	0 of 50
Inactive MJ With 0 mg CBD	0 of 50 (0%)	2 of 50 (4%)	0 of 50
Inactive MJ With 200 mg CBD	0 of 50 (0%)	1 of 50 (2%)	0 of 50
Inactive MJ With 400 mg CBD	0 of 50 (0%)	3 of 50 (6%)	0 of 50
Inactive MJ With 800 mg CBD	0 of 50 (0%)	6 of 50 (12%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Margaret Haney, M.D. principal investigator

New York State Psychiatric Institute

Robert J Malcolm, M.D. study director

Medical University of South Carolina

Sharon Walsh, Ph.D. study director

University of Kentucky

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBD in people with Smoking, Marijuana, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.

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 4 inclusion and 8 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mood Scale - Subscale 'Feeling High' (time frame: two hours before and after marijuana cigarette smoking). 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 NCT01844687.

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 9 Dec 2019.