Methamphetamine-Quetiapine Interactions in Humans

NCT00567866 | Terminated Early Phase 1 DMC

• 1 other identifier: 72900
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

• Behavioral Responses to Methamphetamine following predosing with placebo or test article.

  Prior to drug administration, and 10 minutes post-drug administration and then hourly for 9 hours

Secondary Outcomes (1)

• Physiological Responses to methamphetamine following predosing of placebo or test article

  Pre-drug dosing, 5, 20, 35, and 50 minutes postdosing until 4 hours postodose, and then twice hourly until the seventh hour

Study Arms (3)

1

EXPERIMENTAL

placebo -50 mg quetiapine- 100 mg quetiapine

Drug: Quetiapine

2

EXPERIMENTAL

50 mg quetiapine -100 mg quetiapine- placebo

Drug: Quetiapine

3

EXPERIMENTAL

50 mg quetiapine -placebo- 100 mg quetiapine

Drug: Quetiapine

Interventions

Quetiapine DRUG

50 or 100 mg of quetiapine orally

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be between the ages of 18-50.
• 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.
• 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).
• 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 drugs that would have major interaction with drugs to be tested.
• 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.
• 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
• Body Mass Index \>30 or \<18
• Currently trying to quit methamphetamine use or seeking treatment for methamphetamine use
• History of serious adverse event or hypersensitivity to methamphetamine or other study drugs
• 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
• Use within the last month of the Vicks Nasal Inhaler or medications that are metabolized to methamphetamine (e.g. selegiline)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William Brooks Gentry, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 13, 2010

Record last verified: 2010-07

Locations

US (1)