Phase 1
N=22
Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Cannabis Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01467999 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Reduction in Mean Number of Days of Cannabis Use Per Week — 4.1; 3.1 days of use per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Guanfacine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Mean Number of Days of Cannabis Use Per Week |
4.1; 3.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01467999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.