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

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Guanfacine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis dependence, marijuana dependence, guanfacine

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 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.

Sites / Locations

  • STARS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guanfacine

Arm Description

Guanfacine, 4mg given once daily

Outcomes

Primary Outcome Measures

Reduction in Mean Number of Days of Cannabis Use Per Week
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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2011
Last Updated
January 17, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01467999
Brief Title
Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Acronym
GUAN
Official Title
Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
cannabis dependence, marijuana dependence, guanfacine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine
Arm Type
Experimental
Arm Description
Guanfacine, 4mg given once daily
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Other Intervention Name(s)
Intuniv
Intervention Description
Guanfacine, 4mg given once daily
Primary Outcome Measure Information:
Title
Reduction in Mean Number of Days of Cannabis Use Per Week
Description
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.
Time Frame
Daily cannabis use reported during the 8 week trial or the length of the patient's participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Levin, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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