Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: Guanfacine
Intervention description: Guanfacine, 4mg given once daily
Intervention MeSH terms: Guanfacine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cannabis dependence; marijuana dependence; guanfacine

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.
    

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.