Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
GUAN
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
December 12, 2018
CompletedFebruary 5, 2019
January 1, 2019
4.2 years
November 7, 2011
May 16, 2018
January 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Daily cannabis use reported during the 8 week trial or the length of the patient's participation
Study Arms (1)
Guanfacine
EXPERIMENTALGuanfacine, 4mg given once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
STARS
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to its open-label nature, it is not possible to determine whether the reductions in cannabis use were due to study drug, or whether they were related to other study procedures.
Results Point of Contact
- Title
- daniel brooks
- Organization
- NYSPI
Study Officials
- PRINCIPAL INVESTIGATOR
Frances Levin, M.D.
Columbia University
- PRINCIPAL INVESTIGATOR
Elias Dakwar, M.D.
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Substance Use Disorder
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
February 1, 2012
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
February 5, 2019
Results First Posted
December 12, 2018
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share