Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence (GUAN)

January 17, 2019 updated by: Frances R Levin, New York State Psychiatric Institute
The purpose of this study is to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving as compared to baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 been developed yet. As such, the development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Lofexidine, an alpha-2 agonist, is effective in treating opioid withdrawal and shows promise as cannabis use disorder pharmacotherapy, though its use may be limited by a cumbersome (thrice daily) dosing regimen. An alpha-2-agonist with a longer half-life, such as guanfacine, may have some of the same benefits as lofexidine at comparable doses, but its easier (once daily) dosing regimen may promote compliance and treatment retention. The purpose of this study is therefore to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. This pilot study can also provide the basis for subsequently conducting a larger study aimed at determining efficacy with the appropriate randomized, placebo-controlled design.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • STARS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 20 days in the past 30 days 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.
  • Unstable medication conditions, such as poorly controlled diabetes or hypertension (>140/90 mmHg), which might make participation hazardous.
  • Individuals with liver enzyme function tests greater than three times normal, or acute hepatitis
  • Individuals with a history of a 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 alpha-2 Agonists
  • Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  • Individuals currently being treated with antihypertensive medication, including alpha-2 agonists
  • Individuals currently taking medications that may interact adversely with guanfacine.
  • Individuals who are court-mandated to treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guanfacine
Guanfacine, 4mg given once daily
Drug: Guanfacine
Guanfacine, 4mg given once daily
Other Names:
  • Intuniv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Mean Number of Days of Cannabis Use Per Week
Time Frame: Daily cannabis use reported during the 8 week trial or the length of the patient's participation
The reduction in cannabis consumption quantified by the number of days of cannabis use per week was assessed, as measured by the Time Line followback, reported week 1 compared to week 8.
Daily cannabis use reported during the 8 week trial or the length of the patient's participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Frances Levin, M.D., Columbia University
  • Principal Investigator: Elias Dakwar, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6393
  • 6393 (NYSPI IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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