DOX as a Potential Treatment for Methamphetamine Dependence

NCT02785393 | Completed Phase 1 DMC

• 3 other identifiers: H-26957DPMCP50DA018197
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to asses the potential interactions between methamphetamine and doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of methamphetamine in a human laboratory study. The primary objective is to determine the safety of treatment with doxazosin in methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of methamphetamine and a placebo dose during treatment with doxazosin. The secondary objective is to determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo

Conditions

Substance-Related Disorders

Keywords

Methamphetamine; Dependence

Outcome Measures

Primary Outcomes (2)

• blood pressure, change from baseline

  -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing

• heart rate, change from baseline

  -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing

Secondary Outcomes (1)

• subjective effects of methamphetamine or placebo, change from baseline

  -15 min, 5 min, 15 min, 30 min, 45 min and 60 min after MA dosing

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Drug: Sugar Pill

Doxazosin

ACTIVE COMPARATOR

Drug: Doxazosin

Interventions

Sugar Pill DRUG

The administration of a sugar pill

Sugar Pill

Doxazosin DRUG

The administration of the Doxazosin medication

Doxazosin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be English-speaking volunteers who are not seeking treatment at the time of the study
• Be between 18-55 years of age
• Meet DSM-IV TR criteria for methamphetamine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most methamphetamine users smoke cigarettes.
• Have a self-reported history of using methamphetamine by the smoked or IV route
• Have vital signs as follows: supine blood pressure \> 100/65 mm Hg, a seated blood pressure of \> 90/60 mm Hg, and an orthostatic change \< 20 mm Hg systolic or \<10 mm Hg diastolic on standing. To ensure that subjects will not be at risk from methamphetamine, the resting pulse must be \< 90 bpm and the blood pressure must be \< 150 mmHg systolic and \< 90 mmHg diastolic.
• Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) \< 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) within normal limits
• Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
• Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

You may not qualify if:

• Meet DSM IV TR criteria for dependence on drugs other than methamphetamine or nicotine.
• Have any history or evidence suggestive of seizure disorder or brain injury
• Have any previous medically adverse reaction to methamphetamine, including loss of consciousness, chest pain, or epileptic seizure
• Have neurological or psychiatric disorders, such as:
• psychosis, bipolar illness or major depression as assessed by MINI
• organic brain disease or dementia assessed by clinical interview
• history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult
• history of suicide attempts within the past year and/or current suicidal ideation/plan
• Have evidence of clinically significant heart disease or hypertension, as determined by the PI
• 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
• Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation
• Have asthma or currently use theophylline or other sympathomimetics
• Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
• Criteria for Discontinuation Following Initiation Participants will be discharged if they have a positive breath test indicating use of alcohol or a urine test indicating illicit use of drugs while in the MED-VAMC, if they do not comply with study procedures, or if they do not tolerate the study drugs. Stopping criteria are detailed below.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Michael Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Sugars; Doxazosin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thomas F Newton, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: May 27, 2016
• Study Start: March 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)