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Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Doxazosin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Daryl I Shorter, MD, Principal Investigator, Affiliation: Michael E. DeBakey VA Medical Center, Houston, TX

Overall contact:
Daryl I Shorter, MD, Phone: (713) 791-1414, Ext: 3645, Email: Daryl.Shorter@va.gov

Summary

Cocaine use disorders affect approximately 1. 5 million Americans annually. Currently, there are no US Food and Drug Administration approved medications for treatment of cocaine dependence; however, both animal and human studies suggest that medications affecting the noradrenergic system can reduce cocaine craving and use. We will study the effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety symptoms among cocaine-dependent individuals. In addition, we will identify genetic subpopulations of participants who preferentially respond to the medication.

Clinical Details

Official title: Pharmacogenetic Trial of Noradrenergic Medication for Treatment of Cocaine Abuse

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in cocaine use

Secondary outcome:

Treatment Retention

Adverse events

Changes in cocaine craving

Detailed description: The noradrenergic system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. Doxazosin is a long-acting and selective alpha 1-adrenergic receptor blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system. This study will evaluate the efficacy of doxazosin in reducing cocaine-using behavior in treatment seeking cocaine-dependent individuals, and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for treatment of cocaine addiction. Additionally, this study will identify genetic subpopulations of participants for whom doxazosin is preferentially effective, specifically examining the R492C functional polymorphism of the ADRA1A gene. This 15-week double-blind, placebo controlled clinical trial will provide treatment for 100 cocaine-dependent patients and includes a 13 week medication trial (weeks 1-13) and up to 2 week washout period (weeks 14-15). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation. Subjects will be receiving 2 mg study medication/placebo capsules at week 1, with 2mg/week induction rate for 3 weeks, according to their randomized assignments, and are maintained on these agents through week 13. During the course of the trial, all participants will receive manual-guided cognitive behavioral therapy. At the end of the study (weeks 14-15), participants will undergo discontinuation from active/placebo medication over a 2-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 2 week period (weeks 14-15).

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent form and HIPAA authorization form

- Subject is cooperative, understands the risks and benefits, and is willing and able

to adhere to study requirements.

- Any race or ethnic origin

- Diagnosis of cocaine-dependence according to DSM-IV criteria

- Between the ages of 18 and 64

- Must be current users of cocaine with self-reported use of cocaine, at least one

cocaine-positive urine during screening, and a score over 3 (which is the cut-off for diagnosis of cocaine dependence per the DSM IV-R) as assessed with the Severity of Substance Dependence Scale (Kaye & Darke 2002; Gossop, et al 1995; Gossop, et al. 1997)

- Women of childbearing age are eligible to be included in the study if they have a

negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal toxicity due to medication.

- Must be in good general health as determined by self-report and/or CPRS-based medical

history, general clinical examination conducted by a study physician, and lab tests. HIV testing will be recommended but is not required for participation in this study. CPRS medical records will not be accessed until subject signs the ICF.

- Motivated to discontinue or reduce cocaine use during the period of the study, as

evidenced both by the judgment of the Investigator or designee and by the subject's compliance level with the requirement for attendance at clinic visits, such that weekly urine sample requirements for inclusion criteria are fully met. Exclusion Criteria:

- Current diagnosis of other drug dependence, especially alcohol or benzodiazepine

dependence, or abuse (other than cocaine, tobacco, or cannabis).

- Significant medical conditions (e. g., major cardiovascular, renal, endocrine, hepatic

disorders) such as abnormal liver function (with laboratory findings of SGOT or SGPT greater than three times normal), hypotension or hypertension, a current cardiac condition, and those having a high risk of cardiovascular disease, seizure disorders, or another significant underlying medical condition which would contraindicate Doxazosin treatment.

- Lifetime schizophrenia, bipolar disorder, or other psychotic disorders.

- Actively considering plans of suicidality or homicidality

- Current use of a prescribed psychotropic medication that cannot be discontinued

- Women planning to become pregnant or breastfeed during the study, refusal to use a

reliable form of birth control, or refusal of monthly pregnancy testing

- Subjects who are prescribed certain anti-hypertension drugs including ace inhibitors

and alpha adrenergic blockers will be excluded because these medications may interact with Doxazosin's brain effects in reducing cocaine abuse.

Locations and Contacts

Daryl I Shorter, MD, Phone: (713) 791-1414, Ext: 3645, Email: Daryl.Shorter@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas 77030, United States; Recruiting
Daryl I Shorter, MD, Phone: 713-791-1414, Ext: 3645, Email: Daryl.Shorter@va.gov
Timothy Shutter, MA, Phone: (713) 791-1414, Ext: 4513, Email: shutter@bcm.edu
Daryl I Shorter, MD, Principal Investigator
Additional Information

Starting date: April 2014
Last updated: April 1, 2015

Page last updated: August 23, 2015

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