Methamphetamine-Quetiapine Interactions in Humans

NCT ID: NCT00567866

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-09-30

Brief Summary

This study will test the ability of a medicine (Quetiapine) that is used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it difficult for users to stop using it. This study will test the ability of a medicine that is used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it difficult for users to stop using it. The investigator thinks quetiapine will lessen the effects of methamphetamine.

Detailed Description

The specific goal of this project is to examine whether quetiapine will alter the behavioral effects of methamphetamine without producing major cardiovascular changes or toxic effects under controlled laboratory conditions. This goal will be accomplished using a methamphetamine challenge procedure in which quetiapine will be given orally prior to intravenous (iv) methamphetamine administration. This will allow rapid and systematic evaluation of the therapeutic potential of this medication.

Results of this drug-interaction study will help determine further investigations of the clinical efficacy of this and other dopamine-active agents. We hypothesize that quetiapine will reduce the self-reported, performance and cardiovascular effects of methamphetamine.

Conditions

Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2

50 mg quetiapine -100 mg quetiapine- placebo

Group Type: EXPERIMENTAL

Quetiapine

Intervention Type: DRUG

50 or 100 mg of quetiapine orally

3

50 mg quetiapine -placebo- 100 mg quetiapine

Group Type: EXPERIMENTAL

Quetiapine

Intervention Type: DRUG

50 or 100 mg of quetiapine orally

1

placebo -50 mg quetiapine- 100 mg quetiapine

Group Type: EXPERIMENTAL

Quetiapine

Intervention Type: DRUG

50 or 100 mg of quetiapine orally

Interventions

Quetiapine

50 or 100 mg of quetiapine orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Must be between the ages of 18-50.

2. Must have experience with IV methamphetamine use, with self-reported recent history of weekly use being greater than the total administered in the study. Recent use will be confirmed by a urine toxicology screen positive for amphetamines. We will recruit moderate to frequent users of methamphetamine. Moderate use is defined as use from once or twice every six weeks to weekly. Frequent users are defined as individuals who use greater than weekly.

3. Must have recent use confirmed by a urine toxicology screen positive for amphetamines.

4. Must not be seeking treatment for methamphetamine abuse/dependence.

Exclusion Criteria

1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder).

2. Current diagnosis of other drug or alcohol physical dependence (other than nicotine or caffeine).

3. 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.

4. Pregnancy, plans to become pregnant or fertile women without adequate means of contraception.

5. Present or recent use of over-the-counter or prescription psychoactive drug or drugs that would have major interaction with drugs to be tested.

6. Medical contraindication to or prior serious adverse effects from methamphetamine 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.

7. Current enrollment in a methamphetamine, alcohol, or other drug treatment program or current legal problems relating to methamphetamine, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer

8. Body Mass Index >30 or <18

9. Currently trying to quit methamphetamine use or seeking treatment for methamphetamine use

10. History of serious adverse event or hypersensitivity to methamphetamine or other study drugs

11. Currently taking any medication (including highly active antiretroviral therapy (HAART) for HIV) other than over-the-counter nonsteroidal anti-inflammatory medications, topical medications, inhaled asthma therapy, and over-the-counter nonsedating antihistamines

12. Use within the last month of the Vicks Nasal Inhaler or medications that are metabolized to methamphetamine (e.g. selegiline)

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University of Arkansas for Medical Sciences

Principal Investigators

William Brooks Gentry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

72900

Identifier Type: -

Identifier Source: org_study_id