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Cannabis DependencePhase 2NCT01611948

Treatment for Cannabis Withdrawal and Dependence

A Phase 2 study testing Aprepitant and Manual-guided behavioral counseling in people with Cannabis Dependence, 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

Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in 10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse precipitant. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cannabis Dependence
What is being tested?
Aprepitant and Manual-guided behavioral counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
May 2011to Oct 2015
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females from 18-70 years of age
  • Meets DSM IV criteria for current cannabis dependence
  • Seeking research-based outpatient treatment for cannabis dependence that involves daily oral medication
  • Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
  • Current cannabis use verified by a positive urine test > 50 ng/ml
  • At least a 2-year history of regular MJ use
  • Willing and able to give informed consent

Who cannot join

  • Abstinent from cannabis more than 2 days at the time of randomization
  • Currently meets DSM IV criteria for dependence on substances, or has urine drug screen positive for substances, other than cannabis or nicotine
  • Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
  • Active suicidal ideation
  • Significant medical disorders that will increase potential risk or interfere with study participation,
  • Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use a double-barrier method of birth control during the study and for up to 4 weeks after study termination
Show all 13Show fewer
  • Ongoing treatment with medications that may affect study outcomes,
  • Use of CYP3A4 strong inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) and CYP3A4 moderate inhibitors (e.g., diltiazem) within the 2 week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
  • Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.
  • Ongoing treatment with medications that are primarily metabolized by CYP3A4 and may have increased plasma concentrations when co-administered with aprepitant, such as pimozide, terfenadine, astemizole or cisapride or corticosteroids, as well as benzodiazepines including midazolam, alprazolam, and triazolam.
  • Ongoing treatment with medications that are primarily metabolized by CYP2C9 (e.g., warfarin, tolbutamide).
  • Use of drugs (e.g., rifampin, carbamazepine, phenytoin) or herbal supplements (e.g., St John's wort) that induce CYP3A4 activity and may result in reduced plasma concentrations of aprepitant and decreased efficacy of aprepitant.
  • Inability to understand and/or comply with the provisions of the protocol and consent form.

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: Pharmacological Treatment of Cannabis Withdrawal and Dependence

Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in 10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse precipitant. Cannabis use also impairs executive cognitive functions thereby increasing vulnerability to relapse and reducing the ability to benefit from behavioral therapy. There are no pharmacological treatments for cannabis dependence, despite the large number of afflicted individuals and the limitations of behavioral therapies which do not remediate withdrawal and are associated with high rates of treatment failure. The primary aim of this clinical trial is to evaluate the efficacy and safety of a novel neurokinin1 (NK1) receptor antagonist, aprepitant (Emend), (125mg/day), in outpatients with current cannabis dependence. The main hypothesis to be tested is to evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients, specifically anxiety, mood, craving and sleep.

Read the detailed description

This study will be a Phase II, single-site, 8-week, randomized, double-blind, placebo-controlled, parallel group comparison of aprepitant (125 mg/d) or placebo. Subjects will be 100 outpatients seeking treatment for current cannabis dependence with no clinically significant medical or psychiatric disorders (including substance use disorders or a positive drug screen for substances other than cannabis or nicotine). All subjects will receive weekly manual-guided abstinence-oriented counseling to facilitate showing a drug effect above and beyond available therapies (Weeks 0-8). Research assessments of marijuana use and withdrawal and drug safety and tolerability will occur weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments will occur at Weeks 9 and 12. Neuropsychological testing will occur at Weeks 0 and 4 and 8.

Specific Aim 1: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients, including anxiety, mood, craving and sleep symptoms.

Specific Aim 2: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing marijuana use in cannabis dependent outpatients.

Specific Aim 3: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis related impairments in executive functioning in cannabis dependent outpatients.

Being tested
Aprepitant, Placebo, Manual-guided behavioral counseling
Medical subject headings
Marijuana Abuse

What participants receive

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

  • AprepitantDrug

    Also called Emend

    125mg/day for 8 weeks

  • PlaceboDrug

    125mg/d placebo pill for 8 weeks

  • Manual-guided behavioral counselingBehavioural

    Also called Manual-guided therapy

    Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Study groups in NCT01611948
Study groupRoleWhat they receive
Active DrugActive comparator125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Receives: Drug: Aprepitant; Behavioral: Manual-guided behavioral counseling
Placebo pillPlacebo comparatorPlacebo pill daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Receives: Drug: Placebo; Behavioral: Manual-guided behavioral counseling

What is being measured

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

  1. Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8

    Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).

    Measured: Week 0 and Week 8

Timeline

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

  1. First posted5 Jun 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611948
Sponsor's protocol ID
DA030988
Other IDs
5R01DA030988-05
Status last verified
Mar 2017
First submitted
3 Jun 2011
Last updated
1 May 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aprepitant and Manual-guided behavioral counseling in people with Cannabis Dependence, 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 7 inclusion and 13 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 1 May 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 27 Mar 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?

Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 (time frame: Week 0 and Week 8). 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 NCT01611948.

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 1 May 2017.

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