Back to resultsDoxazosin for Psychostimulant Dependence
Primary Purpose
Methamphetamine or Cocaine Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxazosin extended release
Sponsored by
About this trial
This is an interventional treatment trial for Methamphetamine or Cocaine Dependence
Eligibility Criteria
Inclusion Criteria:
- 18-55 years old
- Methamphetamine OR cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
- At least weekly self-reported methamphetamine OR cocaine use during a preceding three month period
- Urine toxicology screen positive for methamphetamine or methamphetamine metabolite OR cocaine or cocaine metabolite
- Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing
Exclusion Criteria:
- Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
- Current opioid, alcohol or sedative physical dependence or dependence on both cocaine and methamphetamine
- Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
- Any history or evidence suggestive of seizure disorder or brain injury
- Subjects needing or planning cataract surgery.
- History of schizophrenia, major depression, or bipolar type I disorder
- Organic brain disease or dementia assessed by physician
- Use of medications that would be expected to have major interaction with doxazosin (e.g. atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole or any other potent 3A4 inhibitor.,)
- Any previous medically adverse reaction to methamphetamine or cocaine, including loss of consciousness, chest pain, or epileptic seizure
- Medical contraindication to receiving doxazosin (e.g. liver problems or allergies to other to other quinazolines such as prazosin or terazosin)
- Severe gastrointestinal disorder as determined by physician
- Liver function tests (i.e., liver enzymes) greater than three times normal levels
- Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min.
- Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Have symptomatic HIV or are taking antiretroviral medication
- Have asthma or currently use theophylline or other sympathomimetics
- Participants with estimated glomerular filtration rate < 30 ml/min.
- Pregnant or nursing female
Sites / Locations
- UAMS Psychiatric Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Doxazosin
Placebo
Arm Description
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Participants will be maintained on placebo (cellulose) throughout the trial.
Outcomes
Primary Outcome Measures
Change in Psychostimulant-positive Urines Over Time
Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01371851
First Posted
June 9, 2011
Last Updated
July 24, 2015
Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA), Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01371851
Brief Title
Doxazosin for Psychostimulant Dependence
Official Title
Clinical Efficacy of Doxazosin for Psychostimulant Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA), Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Psychostimulant dependence is a major public health problem and no medications have been shown to be very effective in treating this disorder. Thus, the investigators wish to study whether a blood pressure drug thought to reduce drug craving through its interaction at particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in psychostimulant dependent participants enrolled in an 8-week, randomized, double blind, placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce cocaine use relative to placebo in psychostimulant dependent participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine or Cocaine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxazosin
Arm Type
Experimental
Arm Description
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be maintained on placebo (cellulose) throughout the trial.
Intervention Type
Drug
Intervention Name(s)
Doxazosin extended release
Intervention Description
initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
Primary Outcome Measure Information:
Title
Change in Psychostimulant-positive Urines Over Time
Description
Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.
Time Frame
twice-weekly urine samples (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-55 years old
Methamphetamine OR cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
At least weekly self-reported methamphetamine OR cocaine use during a preceding three month period
Urine toxicology screen positive for methamphetamine or methamphetamine metabolite OR cocaine or cocaine metabolite
Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing
Exclusion Criteria:
Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
Current opioid, alcohol or sedative physical dependence or dependence on both cocaine and methamphetamine
Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
Any history or evidence suggestive of seizure disorder or brain injury
Subjects needing or planning cataract surgery.
History of schizophrenia, major depression, or bipolar type I disorder
Organic brain disease or dementia assessed by physician
Use of medications that would be expected to have major interaction with doxazosin (e.g. atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole or any other potent 3A4 inhibitor.,)
Any previous medically adverse reaction to methamphetamine or cocaine, including loss of consciousness, chest pain, or epileptic seizure
Medical contraindication to receiving doxazosin (e.g. liver problems or allergies to other to other quinazolines such as prazosin or terazosin)
Severe gastrointestinal disorder as determined by physician
Liver function tests (i.e., liver enzymes) greater than three times normal levels
Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min.
Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
Have symptomatic HIV or are taking antiretroviral medication
Have asthma or currently use theophylline or other sympathomimetics
Participants with estimated glomerular filtration rate < 30 ml/min.
Pregnant or nursing female
Facility Information:
Facility Name
UAMS Psychiatric Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Doxazosin for Psychostimulant Dependence
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