Back to results

Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)

Primary Purpose

Cannabis Dependence, Marijuana Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dronabinol

Placebo

Lofexidine

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis Dependence, Marijuana Dependence, Marinol, Lofexidine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Sites / Locations

New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lofexidine and Dronabinol

Placebo

Arm Description

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Lofex. matched placebo Dronabinol placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01020019

First Posted

November 24, 2009

Last Updated

April 22, 2019

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01020019

Brief Title

Combined Pharmacotherapy for Cannabis Dependency

Acronym

D-LUCS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Dependence, Marijuana Dependence

Keywords

Cannabis Dependence, Marijuana Dependence, Marinol, Lofexidine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lofexidine and Dronabinol

Arm Type

Experimental

Arm Description

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Lofex. matched placebo Dronabinol placebo

Intervention Type

Drug

Intervention Name(s)

Dronabinol

Other Intervention Name(s)

Marinol

Intervention Description

Dronabinol: 20 mg/TID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo control

Intervention Type

Drug

Intervention Name(s)

Lofexidine

Intervention Description

Lofex: .6 mg/ TID

Primary Outcome Measure Information:

Title

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

Time Frame

reported daily for 12 weeks/ or study participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frances R Levin, M.D.

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29457671

Citation

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.

Results Reference

derived

Learn more about this trial

Combined Pharmacotherapy for Cannabis Dependency

We'll reach out to this number within 24 hrs