Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence (GUAN)
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| First Received Date ICMJE | November 7, 2011 | ||||||||
| Last Updated Date | June 26, 2012 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in cannabis use [ Time Frame: Daily cannabis use reported during the 9 week trial or the length of the patient's participation ] [ Designated as safety issue: Yes ] The reduction in cannabis consumption quantified by the number of days of cannabis use per week, as measured by the Timeline Follow-Back (TLFB) method. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01467999 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence | ||||||||
| Official Title ICMJE | Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence | ||||||||
| 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. |
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| Detailed Description | Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has been developed yet. As such, the development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Lofexidine, an alpha-2 agonist, is effective in treating opioid withdrawal and shows promise as cannabis use disorder pharmacotherapy, though its use may be limited by a cumbersome (thrice daily) dosing regimen. An alpha-2-agonist with a longer half-life, such as guanfacine, may have some of the same benefits as lofexidine at comparable doses, but its easier (once daily) dosing regimen may promote compliance and treatment retention. The purpose of this study is therefore to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. This pilot study can also provide the basis for subsequently conducting a larger study aimed at determining efficacy with the appropriate randomized, placebo-controlled design. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cannabis Dependence | ||||||||
| Intervention ICMJE | Drug: Guanfacine
Guanfacine, 4mg given once daily |
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| Study Arm (s) | Experimental: Guanfacine
Guanfacine, 4mg given once daily
Intervention: Drug: Guanfacine |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | March 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01467999 | ||||||||
| Other Study ID Numbers ICMJE | #6393, 6393 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | New York State Psychiatric Institute | ||||||||
| Study Sponsor ICMJE | New York State Psychiatric Institute | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | New York State Psychiatric Institute | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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