Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin

NCT01178138 | Completed Phase 2 Results DMC

• 2 other identifiers: 1103711R01DA026916-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will test the safety, effectiveness and the metabolism and action of prazosin as a potential therapy for methamphetamine abuse. This will be accomplished by performing a series of human laboratory studies. In each of these studies, the safety and effectiveness of the test medication (prazosin) in the treatment of methamphetamine effects will be determined. The study hypothesis is that prazosin will block the methamphetamine receptor function, reducing the reinforcing effects of central nervous system effects in humans.

Conditions

Continuous Methamphetamine Abuse

Keywords

substance abuse

Outcome Measures

Primary Outcomes (3)

• Self-report Effects of High.

  Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales. Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect). In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again.

  0 hr time point after prazosin and 1 hr time point after methamphetamine

• Heart Effects of Prazosin on Methamphetamine

  Heart effects of prazosin on methamphetamine; In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again.

  0 hr time point after prazosin and 1 hr time point after methamphetamine

• Blood Pressure Effects of Prazosin on Methamphetamine

  Blood pressure effects of prazosin on methamphetamine; In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again.

  0 hr time point after prazosin and 1 hr time point after methamphetamine

Study Arms (1)

Prazosin effects on methamphetamine

OTHER

Randomized placebo controlled trial of prazosin effects on methamphetamine

Drug: Prazosin

Interventions

Prazosin DRUG

Prazosin or oral placebo given before methamphetamine or iv placebo to determine effects of prazosin on methamphetamine.

Also known as: Minipress

Prazosin effects on methamphetamine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be between the ages of 18-50 years (inclusive).
• Must be a current methamphetamine user, with self-reported amount of IV use being greater than the total administered in the study.
• Must have recent use confirmed by a urine toxicology screen positive for amphetamines.
• Must not be seeking treatment for methamphetamine abuse/dependence.

You may not qualify if:

• Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
• Current diagnosis of other drug or alcohol physical dependence (other than nicotine or caffeine).
• History of major organic psychiatric disorder (psychosis, schizophrenia, bipolar, mania) or significant psychiatric symptoms at the time of evaluation for study participation, including suicidal ideation.
• Pregnancy, plans to become pregnant, or fertile women without adequate means of contraception.
• Present or recent use of over-the-counter or prescription psychoactive drug or drug that would have major interaction with drugs to be tested.
• Liver function tests greater than three times normal, blood urea nitrogen and creatinine outside of normal range, or thyroid function tests outside of normal range.
• EKG abnormalities including but not limited to: bradycardia (\<60 bpm); prolonged corrected QT interval interval (\>450 msec); Wolff-Parkinson-White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
• Medical contraindication to or prior serious adverse effects from METH or stimulants (i.e., seizures, cardiac arrest) or medical contraindication to test agents (see risks section). Significant physical or psychiatric illness which might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
• Current enrollment in a methamphetamine, alcohol, or other drug treatment program or current legal problems relating to METH, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer.
• Left ventricular ejection fraction \< 40% as determined in the screening echocardiogram.
• Body Mass Index \>35 or \<18.
• Currently trying to quit METH use.
• History of serious adverse event or hypersensitivity to methamphetamine or other study drugs
• Currently taking any medication (including highly active antiretroviral therapy for HIV) other than over-the-counter nonsteroidal anti-inflammatory medications, topical medications, inhaled asthma therapy, and over-the-counter nonsedating antihistamines.
• Any other condition the PI or staff feels will put the subject at risk for entering the study.

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

24 enrolled, 3 started study (1 withdrew after 5 sessions, 1 after 3 sessions; both for personal reasons), 1 completed. Data were collected on sessions completed.

Results Point of Contact

• Title: W. Brooks Gentry, MD
• Organization: University of Arkansas for Medical Sciences

gentrywilliamb@uams.edu

501 686 6119

Study Officials

• William B Gentry, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 9, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 30, 2016
• Results First Posted: September 8, 2014

Record last verified: 2016-11

Locations

US (1)