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Cannabis DependencePhase 2/3D-LUCSNCT01020019

Combined Pharmacotherapy for Cannabis Dependency

A Phase 2/3 study testing Dronabinol and Lofexidine in people with Cannabis Dependence and Marijuana Dependence, run by New York State Psychiatric 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

The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cannabis Dependence, Marijuana Dependence
What is being tested?
Dronabinol and Lofexidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
1 siteUnited States
Study dates
Jan 2010to Sep 2014
Phase
Phase 2/3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence
  • Individuals must report using marijuana at least 5 days a week and have a positive urine test for THC on the day of study entry.
  • Individual must describe marijuana as their primary drug of abuse.
  • Individuals must be capable of giving informed consent and capable of complying with study procedures.

Who cannot join

  • Meets DSM-IV-TR criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention.
  • Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
  • Individuals with liver enzyme function tests greater than three times normal
  • Individuals with a history of seizure disorder
  • Individuals with current suicidal risk.
  • Individuals who are cognitively impaired
Show all 15Show fewer
  • Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing).
  • Nursing mothers and pregnant women. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
  • Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
  • Individuals with known sensitivity to dronabinol or lofexidine
  • Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  • Individuals currently being treated with an alpha-2 agonist antihypertensive medication
  • Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month.
  • Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver)
  • Individuals who are court-mandated to treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence

The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.

Read the detailed description

Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has yet to been developed. The development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy strategies have been effective for other substance use disorders (e.g., opioid and nicotine use disorders) and the endocannabinoid system represents a promising target for agonist pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy. Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this combined pharmacotherapy relative to either medication alone or placebo. The proposed protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that dronabinol will act as an agonist treatment while lofexidine will suppress craving- and cue-induced related stress such that the combination will act in a complementary manner to induce prolonged abstinence from marijuana.

Being tested
Dronabinol, Placebo, Lofexidine
Keywords
Cannabis Dependence, Marijuana Dependence, Marinol, Lofexidine
Medical subject headings
Marijuana Abuse

What participants receive

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

  • DronabinolDrug

    Also called Marinol

    Dronabinol: 20 mg/TID

  • PlaceboDrug

    Placebo control

  • LofexidineDrug

    Lofex: .6 mg/ TID

Study groups in NCT01020019
Study groupRoleWhat they receive
Lofexidine and DronabinolExperimentalMaintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Receives: Drug: Dronabinol; Drug: Lofexidine
PlaceboPlacebo comparatorLofex. matched placebo Dronabinol placebo
Receives: Drug: Placebo

What is being measured

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

  1. 21 Days of Consecutive Abstinence as Measured by the Time-line Followback.

    Measured: reported daily for 12 weeks/ or study participation

Timeline

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

  1. First posted25 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2014
  4. Study completionSep 2014

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020019
Sponsor's protocol ID
#6015
Other IDs
P50DA009236-16
Acronym
D-LUCS
Status last verified
Apr 2019
First submitted
24 Nov 2009
Last updated
24 Apr 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Brezing CA, Choi CJ, Pavlicova M, Brooks D, Mahony AL, Mariani JJ, Levin FR. Abstinence and reduced frequency of use are associated with improvements in quality of life among treatment-seekers with cannabis use disorder. Am J Addict. 2018 Mar;27(2):101-107. doi: 10.1111/ajad.12660. Epub 2018 Feb 19.

    PubMed 29457671

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dronabinol and Lofexidine in people with Cannabis Dependence and Marijuana Dependence, run by New York State Psychiatric 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 4 inclusion and 15 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 Apr 2019. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 May 2016). 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?

21 Days of Consecutive Abstinence as Measured by the Time-line Followback. (time frame: reported daily for 12 weeks/ or study participation). 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 NCT01020019, which also lists 1 linked publication.

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 Apr 2019.

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Combined Pharmacotherapy for Cannabis Dependency | AzTrials