Cannabis DependencePhase 2SCCANNCT00656487

Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

A Phase 2 study testing rimonabant in people with Cannabis Dependence and Cannabis Withdrawal, run by The Scripps Research Institute at 1 site 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 21 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis Dependence, Cannabis Withdrawal
What is being tested?: rimonabant
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2008to 6 Jan 2011
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 21 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

males or females 21-30 years of age
meets Diagnostic and Statistical Manual (DSM-IV) diagnosis of Cannabis Dependence
willing to be abstinent for 28 days during study
smokes < 10 cigarettes per day
drinks < 1 (female) or < 2 (male) per day

Who cannot join

active suicide ideation
meets DSM-IV diagnosis for dependence on other substances other than cannabis
significant medical disorders
pregnant women
meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence
currently taking psychoactive medication

Trial locations and contacts

1 site in 1 country.

United States1 site

The Scripps Research Institute
La Jolla, California, 92037

Other trials in United States

About this study

Official title: Translational Center on the Clinical Neurobiology of Cannabis Addiction

The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.

Conditions: Cannabis Dependence, Cannabis Withdrawal
Being tested: rimonabant, placebo
Keywords: Cannabis Dependence, Marijuana Dependence, Cannabis Withdrawal, Rimonabant, cannabinoid receptor type 1 (CB1) inverse agonist, Neuropsychology, functional magnetic resonance imaging (fMRI), Endocannabinoids, Cortisol
Medical subject headings: Marijuana Abuse

What participants receive

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

rimonabantDrug
Also called CB1 receptor antagonist
double blind, placebo controlled, single 90 mg dose
placeboDrug
matched placebo

Study groups in NCT00656487
Study group	Role	What they receive
Cannabis-dependent rimonabant	Experimental	Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post. Receives: Drug: rimonabant
Cannabis-dependent placebo	Placebo comparator	Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post. Receives: Drug: placebo
Non-cannabis using control	No intervention	Non-cannabis using demographically similar young adults followed for 28 days.

What is being measured

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

Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period
The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.
Measured: Day 28
Plasma Norepinephrine
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Measured: Day 28
Plasma Cortisol
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Measured: Day 28
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Measured: Day 0 and Day 28
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Measured: Day 0 and Day 28
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.
Measured: Day 0 and Day 28

Timeline

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

30 Apr 20086 Jan 2011

First posted11 Apr 2008 (estimated)
Study start30 Apr 2008
Primary completion28 Dec 2010
Study completion6 Jan 2011

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 Cannabis DependenceStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00656487
Sponsor's protocol ID: DA024194
Other IDs: P20DA024194
Acronym: SCCAN
Status last verified: May 2017
First submitted: 7 Apr 2008
Last updated: 19 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
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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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Translational Center on the Clinical Neurobiology of Cannabis Addiction
ClinicalTrials.gov ID: NCT00656487
Acronym / sponsor ID: SCCAN / DA024194
Conditions: Cannabis Dependence, Cannabis Withdrawal
Keywords: Cannabis Dependence, Marijuana Dependence, Cannabis Withdrawal, Rimonabant, cannabinoid receptor type 1 (CB1) inverse agonist, Neuropsychology, functional magnetic resonance imaging (fMRI), Endocannabinoids
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: The Scripps Research InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 30 Apr 2008 (actual)
Primary completion: 28 Dec 2010 (actual)
Study completion: 6 Jan 2011 (actual)
First posted: 11 Apr 2008 (estimated)
Results: Posted 15 May 2017

Clinical summary

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cannabis-dependent rimonabant	Experimental	Drug: rimonabantCannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.
Cannabis-dependent placebo	Placebo comparator	Drug: placeboCannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.
Non-cannabis using control	No intervention	–Non-cannabis using demographically similar young adults followed for 28 days.

Who may qualify

Ages: 21 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

males or females 21-30 years of age
meets Diagnostic and Statistical Manual (DSM-IV) diagnosis of Cannabis Dependence
willing to be abstinent for 28 days during study
smokes < 10 cigarettes per day
drinks < 1 (female) or < 2 (male) per day

Key exclusion criteria (6 listed)

active suicide ideation
meets DSM-IV diagnosis for dependence on other substances other than cannabis
significant medical disorders
pregnant women
meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence

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
rimonabantAlso: CB1 receptor antagonistdouble blind, placebo controlled, single 90 mg dose	Drug	Cannabis-dependent rimonabant
placebomatched placebo	Drug	Cannabis-dependent placebo

Primary outcome

Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period
Time frame: Day 28
The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.
Plasma Norepinephrine
Time frame: Day 28
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Plasma Cortisol
Time frame: Day 28
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28
Time frame: Day 0 and Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28
Time frame: Day 0 and Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28
Time frame: Day 0 and Day 28
The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.

Results and safety

Results posted to the registry on 15 May 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
Rimonabant	23	21
Placebo	23	19
Control	20	20

Primary outcome: Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period

Time frame: Day 28. Mean (Standard Deviation). Unit: units on a scale

Measure	Rimonabant n = 21	Placebo n = 19	Control n = 19
Value	6.62 (5.59)	6.68 (7.87)	1.05 (2.39)

Population analysed: One participant in the control group who completed monitoring during the double-blind portion of the trial did not complete a Marijuana Withdrawal Checklist at Day 28.

Primary outcome: Plasma Norepinephrine

Time frame: Day 28. Mean (Standard Deviation). Unit: ng/mL

Measure	Rimonabant n = 21	Placebo n = 19	Control n = 15
Value	2.12 (1.14)	2.04 (1.05)	1.75 (0.84)

Population analysed: Five control participants who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. Two participants did not have blood drawn; two additional participant sample results were not returned by the laboratory; and one participant did not return a result due to an ELISA kit error.

Primary outcome: Plasma Cortisol

Time frame: Day 28. Mean (Standard Deviation). Unit: ug/dL

Measure	Rimonabant n = 21	Placebo n = 18	Control n = 18
Value	27.36 (15.03)	19.29 (7.42)	22.72 (15.21)

Population analysed: Two control participants and one placebo participant who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. The control participants did not have blood drawn; the placebo participant returned a non-detectable value.

Primary outcome: Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28

Time frame: Day 0 and Day 28. Mean (Standard Deviation). Unit: units on a scale

Measure	Rimonabant n = 21	Placebo n = 19	Control n = 20
Value	-2.67 (4.15)	-1.37 (5.16)	-1.50 (3.62)

Adverse events

Time frame: Adverse event data was collected at all ten study visits, an average duration of 28 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rimonabant	0 of 23 (0%)	10 of 23 (43.5%)	Not reported
Placebo	0 of 23 (0%)	10 of 23 (43.5%)	Not reported
Control	0 of 20 (0%)	4 of 20 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
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.

Barbara J Mason, Ph.D. principal investigator

The Scripps Research Institute

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 rimonabant in people with Cannabis Dependence and Cannabis Withdrawal, run by The Scripps Research Institute at 1 site 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 5 inclusion and 6 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 19 Jun 2017. 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 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. 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?

Yes. Results are posted in the registry (first posted 15 May 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?

Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period (time frame: Day 28). The study lists 6 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 NCT00656487.

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 19 Jun 2017.