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

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ClinicalTrials.gov Identifier: NCT01467999
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cannabis Dependence
Intervention Drug: Guanfacine
Enrollment 22
Recruitment Details Participants responded to newspapers, radio and public service announcements in the New York City area, and reported at least 20 days of use in the past 30 days.
Pre-assignment Details  
Arm/Group Title Guanfacine
Hide Arm/Group Description

Guanfacine, 4mg given once daily

Guanfacine: Guanfacine, 4mg given once daily

Period Title: Overall Study
Started 22
Completed 9
Not Completed 13
Arm/Group Title Guanfacine
Hide Arm/Group Description

Guanfacine, 4mg given once daily

Guanfacine: Guanfacine, 4mg given once daily

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
36.1  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
8
  36.4%
Male
14
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
2
   9.1%
Not Hispanic or Latino
20
  90.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
4
  18.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  22.7%
White
5
  22.7%
More than one race
6
  27.3%
Unknown or Not Reported
2
   9.1%
1.Primary Outcome
Title Reduction in Cannabis Use
Hide Description 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.
Time Frame Daily cannabis use reported during the 9 week trial or the length of the patient's participation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guanfacine
Hide Arm/Group Description:

Guanfacine, 4mg given once daily

Guanfacine: Guanfacine, 4mg given once daily

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: days
week 1 4.1  (0.6)
week 8 3.1  (0.9)
Time Frame during 8 weeks of open label participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guanfacine
Hide Arm/Group Description

Guanfacine, 4mg given once daily

Guanfacine: Guanfacine, 4mg given once daily

All-Cause Mortality
Guanfacine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Guanfacine
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guanfacine
Affected / at Risk (%) # Events
Total   14/22 (63.64%)    
Cardiac disorders   
hypotension   3/22 (13.64%)  3
Gastrointestinal disorders   
constipation   2/22 (9.09%)  2
nausea   3/22 (13.64%)  3
General disorders   
drowsiness   3/22 (13.64%)  3
dry mouth   5/22 (22.73%)  5
fatigue   5/22 (22.73%)  5
headache   1/22 (4.55%)  1
increased urination   1/22 (4.55%)  1
insomnia   5/22 (22.73%)  5
lightheadedness   4/22 (18.18%)  4
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: daniel brooks
Organization: NYSPI
Phone: 6467746171
Responsible Party: Frances R Levin, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01467999     History of Changes
Other Study ID Numbers: #6393
6393 ( Other Identifier: NYSPI IRB )
First Submitted: November 7, 2011
First Posted: November 9, 2011
Results First Submitted: May 16, 2018
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018