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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Guanfacine

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.