Methamphetamine DependenceEarly Phase 1NCT00567866
Methamphetamine-Quetiapine Interactions in Humans
A Early Phase 1 study testing Quetiapine in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Methamphetamine-Quetiapine Interaction in Humans: A Pilot Study
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.
Read the 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
- Being tested
- Quetiapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
50 or 100 mg of quetiapine orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | placebo -50 mg quetiapine- 100 mg quetiapine Receives: Drug: Quetiapine |
| 2 | Experimental | 50 mg quetiapine -100 mg quetiapine- placebo Receives: Drug: Quetiapine |
| 3 | Experimental | 50 mg quetiapine -placebo- 100 mg quetiapine Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Responses to Methamphetamine following predosing with placebo or test article.
Measured: 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
Measured: Pre-drug dosing, 5, 20, 35, and 50 minutes postdosing until 4 hours postodose, and then twice hourly until the seventh hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Study was terminated due to insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- William Brooks Gentry, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567866
- Sponsor's protocol ID
- 72900
- Status last verified
- Jul 2010
- First submitted
- 3 Dec 2007
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methamphetamine-Quetiapine Interaction in Humans: A Pilot Study
- ClinicalTrials.gov ID
- NCT00567866
- Acronym / sponsor ID
- 72900
- Conditions
- Methamphetamine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to insufficient funds
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Quetiapineplacebo -50 mg quetiapine- 100 mg quetiapine |
| 2 | Experimental | Drug: Quetiapine50 mg quetiapine -100 mg quetiapine- placebo |
| 3 | Experimental | Drug: Quetiapine50 mg quetiapine -placebo- 100 mg quetiapine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine50 or 100 mg of quetiapine orally | Drug | 1, 2, 3 |
Primary outcome
Behavioral Responses to Methamphetamine following predosing with placebo or test article.
Time frame: Prior to drug administration, and 10 minutes post-drug administration and then hourly for 9 hours
1 secondary outcome
Physiological Responses to methamphetamine following predosing of placebo or test article
Time frame: Pre-drug dosing, 5, 20, 35, and 50 minutes postdosing until 4 hours postodose, and then twice hourly until the seventh hour
Results and safety
The study was stopped early (reason given: Study was terminated due to insufficient funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Brooks Gentry, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quetiapine in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to insufficient funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Responses to Methamphetamine following predosing with placebo or test article. (time frame: Prior to drug administration, and 10 minutes post-drug administration and then hourly for 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.