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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00880997 |
Purpose
Doxazosin, an alpha 1-adrenergic receptor may play an important role in cocaine addiction in human. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine addicts.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Doxazosin Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study |
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Doxazosin: Experimental
The starting dose will be 1 mg once daily at week 1 of the overall 17 week study, then 2 mg at week 2, with 1mg/week induction rate for 8 weeks. The target dose of 8 mg daily will probably not be attained by some patients over a 8 week induction period. We will try to increase their dose up to a minimum of 4 mg and optimum of 8 mg daily as daily dosing. |
Drug: Doxazosin
The target dose of 8 mg will probably not be attained by some patients over a 8 week induction period (starting at week 1 of the overall 17 week study). We will try to increase the subjects' dose up to a minimum of 4 mg and optimum of 8 mg daily as once daily dosing. The starting dose will be 1 mg once daily at week 1, then 2 mg once daily at week 2, with 1mg/week induction rate for 8 weeks. They will be maintained on 4mg-8mg daily dosing until week 13. The subjects will be undergo the discontinuation from the study medication during weeks 14 -17.
|
| placebo: Placebo Comparator |
Drug: Doxazosin
The target dose of 8 mg will probably not be attained by some patients over a 8 week induction period (starting at week 1 of the overall 17 week study). We will try to increase the subjects' dose up to a minimum of 4 mg and optimum of 8 mg daily as once daily dosing. The starting dose will be 1 mg once daily at week 1, then 2 mg once daily at week 2, with 1mg/week induction rate for 8 weeks. They will be maintained on 4mg-8mg daily dosing until week 13. The subjects will be undergo the discontinuation from the study medication during weeks 14 -17.
Drug: Placebo
Placebo daily dosing
|
The NE system, especially the alpha 1-adrenergic receptor may play an important role in cocaine addiction in human. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.
This 17-week double-blind, placebo controlled clinical trial will provide treatment for 16 cocaine-dependent patients and includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17).
Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.
Subjects will be receiving 1 mg study medication/placebo capsules at week 1, with 1mg/week induction rate for 8 weeks, according to their randomized assignments, and are maintained on these agents through week 13. At the end of the study (weeks 14-17), participants will undergo discontinuation from active/placebo medication over a 4-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 4 week period (weeks 14-17).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Guiying G Wu, MD | 713-791-1414 ext 4522 | ggwu@bcm.edu |
| Contact: Xiang Y Zhang, MD,PhD | 713-791-1414 ext 5824 | xyzhang@bcm.edu |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Thomas R Kosten, MD | Baylor College of Medicine |
More Information
| Responsible Party: | Baylor College of Medicine ( Thomas Kosten, MD ) |
| Study ID Numbers: | NIDA-18197-4, P50-DA18197-04, DPMCDA |
| Study First Received: | April 13, 2009 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00880997 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cocaine Dependence Substance Related Disorders |
|
Cocaine-Related Disorders Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents |
Anesthetics, Local Doxazosin Dopamine Mental Disorders Substance-Related Disorders Vasoconstrictor Agents Adrenergic Antagonists Dopamine Agents Peripheral Nervous System Agents Cocaine |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Anesthetics Mental Disorders Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Substance-Related Disorders |
Cocaine Cocaine-Related Disorders Central Nervous System Depressants Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions Anesthetics, Local Doxazosin Dopamine Agents Adrenergic Antagonists Peripheral Nervous System Agents Central Nervous System Agents |
