Continuous Methamphetamine AbusePhase 2MATMANCT01178138
Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin
A Phase 2 study testing Prazosin in people with Continuous Methamphetamine Abuse, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Continuous Methamphetamine Abuse
- What is being tested?
- Prazosin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
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
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.
Read the detailed description
Methamphetamine (METH) use has increased in the US and worldwide in the past years. Although associated with profound medical, psychiatric, legal, and social problems, no effective medicines for METH abuse have been identified or approved for human use. It is vitally important to identify compounds that alter METH effects without increasing the risk of METH toxicity. While the brain chemical transmitter dopamine plays a major role in the pleasurable reinforcing and psychomotor stimulant effects of amphetamines, the transmitters norepinephrine and serotonin also contribute substantially to these effects. Recent evidence suggests that the functional links that exist between norepinephrine and serotonin systems may be profoundly important in METH effects and dependence. However, these neurotransmitter systems have not been tested as extensively as targets of pharmacologic interventions. Thus, the purpose of this study is to examine whether the alpha-1-b antagonist prazosin blocks the self-reported effects, cognitive performance and cardiovascular effects of METH in a dose-related manner. Subsequent protocols will test the effect of the serotonin antagonist, cyproheptadine, and the combined norepinephrine/serotonin antagonist, quetiapine. Healthy, non-treatment-seeking METH users will be recruited. They will undergo extensive prestudy medical and psychiatric screening. Twelve volunteers (ages 18-50 years; 50% female; 10% Minority) who sign the informed consent will be recruited to complete the study on prazosin.
METH-abusing volunteers will undergo 6 sessions spaced 2-3 days apart. A single oral dose of prazosin (placebo, 1 mg, or 2 mg po) will be given in a randomized, double-blind design before METH or METH placebo administration in each session. METH will be given po in a dose (20 mg) that is well-tolerated by humans but that results in easily measurable effects by itself (Cruickshank and Dyer, 2009; Sevak et al, 2009; Parrot et al, 2011). Prior to and at several time points after prazosin/placebo,METH/placebo, or prazosin/METH administrations, self-report, cognitive performance and physiologic measures will be obtained.
The studies we propose are significant as they have the potential to identify treatment medications and elucidate new mechanisms of action and desirable characteristics for future medications development. Understanding the effects of treatment drugs in the context of concomitant METH use is an essential component of identifying potential pharmacotherapies for METH dependence that 1) alters the self-reported/performance effects 2) alters the cardiovascular effects and 3) alters the concentration-effect (pharmacodynamic) relationships of METH in human METH users. Using this broad pharmacologic approach to these human laboratory studies will provide insight into the appropriate combination of positive treatment effects with minimal side effects for the ultimate development of a successful treatment for METH abuse. The results should be generalizable to METH abusers and to the development of new treatments for METH abuse that will benefit all members of society. Understanding pharmacologic interactions will lessen complications of drug abuse and provide more rapid introduction of effective new treatments into medical practice.
- Conditions
- Continuous Methamphetamine Abuse
- Being tested
- Prazosin
- Keywords
- substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrazosinDrug
Also called Minipress
Prazosin or oral placebo given before methamphetamine or iv placebo to determine effects of prazosin on methamphetamine.
| Study group | Role | What they receive |
|---|---|---|
| Prazosin effects on methamphetamine | Other | Randomized placebo controlled trial of prazosin effects on methamphetamine Receives: Drug: Prazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 hr time point after prazosin and 1 hr time point after methamphetamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Continuous Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- William B Gentry, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178138
- Sponsor's protocol ID
- 110371
- Other IDs
- 1R01DA026916-01
- Acronym
- MATMA
- Status last verified
- Nov 2016
- First submitted
- 4 Aug 2010
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin
- ClinicalTrials.gov ID
- NCT01178138
- Acronym / sponsor ID
- MATMA / 110371
- Conditions
- Continuous Methamphetamine Abuse
- Keywords
- substance abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methamphetamine (METH) use has increased in the US and worldwide in the past years. Although associated with profound medical, psychiatric, legal, and social problems, no effective medicines for METH abuse have been identified or approved for human use. It is vitally important to identify compounds that alter METH effects without increasing the risk of METH toxicity. While the brain chemical transmitter dopamine plays a major role in the pleasurable reinforcing and psychomotor stimulant effects of amphetamines, the transmitters norepinephrine and serotonin also contribute substantially to these effects. Recent evidence suggests that the functional links that exist between norepinephrine and serotonin systems may be profoundly important in METH effects and dependence. However, these neurotransmitter systems have not been tested as extensively as targets of pharmacologic interventions. Thus, the purpose of this study is to examine whether the alpha-1-b antagonist prazosin blocks the self-reported effects, cognitive performance and cardiovascular effects of METH in a dose-related manner. Subsequent protocols will test the effect of the serotonin antagonist, cyproheptadine, and the combined norepinephrine/serotonin antagonist, quetiapine. Healthy, non-treatment-seeking METH users will be recruited. They will undergo extensive prestudy medical and psychiatric screening. Twelve volunteers (ages 18-50 years; 50% female; 10% Minority) who sign the informed consent will be recruited to complete the study on prazosin.
METH-abusing volunteers will undergo 6 sessions spaced 2-3 days apart. A single oral dose of prazosin (placebo, 1 mg, or 2 mg po) will be given in a randomized, double-blind design before METH or METH placebo administration in each session. METH will be given po in a dose (20 mg) that is well-tolerated by humans but that results in easily measurable effects by itself (Cruickshank and Dyer, 2009; Sevak et al, 2009; Parrot et al, 2011). Prior to and at several time points after prazosin/placebo,METH/placebo, or prazosin/METH administrations, self-report, cognitive performance and physiologic measures will be obtained.
The studies we propose are significant as they have the potential to identify treatment medications and elucidate new mechanisms of action and desirable characteristics for future medications development. Understanding the effects of treatment drugs in the context of concomitant METH use is an essential component of identifying potential pharmacotherapies for METH dependence that 1) alters the self-reported/performance effects 2) alters the cardiovascular effects and 3) alters the concentration-effect (pharmacodynamic) relationships of METH in human METH users. Using this broad pharmacologic approach to these human laboratory studies will provide insight into the appropriate combination of positive treatment effects with minimal side effects for the ultimate development of a successful treatment for METH abuse. The results should be generalizable to METH abusers and to the development of new treatments for METH abuse that will benefit all members of society. Understanding pharmacologic interactions will lessen complications of drug abuse and provide more rapid introduction of effective new treatments into medical practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prazosin effects on methamphetamine | Other | Drug: PrazosinRandomized placebo controlled trial of prazosin effects on methamphetamine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| PrazosinAlso: MinipressPrazosin or oral placebo given before methamphetamine or iv placebo to determine effects of prazosin on methamphetamine. | Drug | Prazosin effects on methamphetamine |
Primary outcome
Self-report Effects of High.
Time frame: 0 hr time point after prazosin and 1 hr time point after methamphetamine
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.
Heart Effects of Prazosin on Methamphetamine
Time frame: 0 hr time point after prazosin and 1 hr time point after 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.
Blood Pressure Effects of Prazosin on Methamphetamine
Time frame: 0 hr time point after prazosin and 1 hr time point after 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 B 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 Phase 2 study testing Prazosin in people with Continuous Methamphetamine Abuse, 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 15 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: finished, as of the sponsor's last update on 30 Dec 2016. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-report Effects of High. (time frame: 0 hr time point after prazosin and 1 hr time point after methamphetamine). The study lists 3 primary outcomes in all. 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 30 Dec 2016.