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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01467999
First received: November 7, 2011
Last updated: August 8, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cannabis Dependence
Drug: Guanfacine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Reduction in cannabis use [ Time Frame: Daily cannabis use reported during the 9 week trial or the length of the patient's participation ] [ Designated as safety issue: Yes ]
    The reduction in cannabis consumption quantified by the number of days of cannabis use per week, as measured by the Timeline Follow-Back (TLFB) method.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guanfacine
Guanfacine, 4mg given once daily
Drug: Guanfacine
Guanfacine, 4mg given once daily
Other Name: Intuniv

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467999

Locations
United States, New York
STARS
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances Levin, M.D. Columbia University
Principal Investigator: Elias Dakwar, M.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01467999     History of Changes
Other Study ID Numbers: #6393, 6393
Study First Received: November 7, 2011
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
cannabis dependence
marijuana dependence
guanfacine

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014