Doxazosin for Psychostimulant Dependence

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01371851
First received: June 9, 2011
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 delay relapse relative to placebo in psychostimulant dependent participants who attain 2 weeks of abstinence. Our hypothesis is that doxazosin will prolong abstinence relative to placebo in psychostimulant dependent participants.


Condition Intervention Phase
Methamphetamine or Cocaine Dependence
Drug: Doxazosin extended release
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Doxazosin for Psychostimulant Dependence

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • First Methamphetamine- or Cocaine-Positive Urine [ Time Frame: thrice-weekly urine samples (two weeks) ] [ Designated as safety issue: No ]
    Time to lapse/relapse will be determined via thrice-weekly urine drug screens.


Enrollment: 22
Study Start Date: June 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxazosin
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.
Drug: Doxazosin extended release
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.
Placebo Comparator: Placebo
Participants will be maintained on placebo (cellulose) throughout the trial.
Drug: Doxazosin extended release
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371851

Locations
United States, Arkansas
UAMS Psychiatric Research Institute
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01371851     History of Changes
Other Study ID Numbers: 2-P50-DA018197-DoxMeth
Study First Received: June 9, 2011
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Doxazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014