Substance-Related DisordersPhase 1DOX-MethNCT02785393
DOX as a Potential Treatment for Methamphetamine Dependence
A Phase 1 study testing Sugar Pill and Doxazosin in people with Substance-Related Disorders, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to asses the potential interactions between methamphetamine and doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of methamphetamine in a human laboratory study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Sugar Pill and Doxazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2016
- Phase
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be English-speaking volunteers who are not seeking treatment at the time of the study
- Be between 18-55 years of age
- Meet DSM-IV TR criteria for methamphetamine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most methamphetamine users smoke cigarettes.
- Have a self-reported history of using methamphetamine by the smoked or IV route
- Have vital signs as follows: supine blood pressure > 100/65 mm Hg, a seated blood pressure of > 90/60 mm Hg, and an orthostatic change < 20 mm Hg systolic or <10 mm Hg diastolic on standing. To ensure that subjects will not be at risk from methamphetamine, the resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.
- Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) within normal limits
- Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.
Who cannot join
- Meet DSM IV TR criteria for dependence on drugs other than methamphetamine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury
- Have any previous medically adverse reaction to methamphetamine, including loss of consciousness, chest pain, or epileptic seizure
- Have neurological or psychiatric disorders, such as:
- psychosis, bipolar illness or major depression as assessed by MINI
- organic brain disease or dementia assessed by clinical interview
Show all 16Show fewer
- history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult
- history of suicide attempts within the past year and/or current suicidal ideation/plan
- Have evidence of clinically significant heart disease or hypertension, as determined by the PI
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- Have symptomatic HIV or are taking antiretroviral medication
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation
- Have asthma or currently use theophylline or other sympathomimetics
- Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
- Criteria for Discontinuation Following Initiation Participants will be discharged if they have a positive breath test indicating use of alcohol or a urine test indicating illicit use of drugs while in the MED-VAMC, if they do not comply with study procedures, or if they do not tolerate the study drugs. Stopping criteria are detailed below.
- Subject Selection Criteria Rationale Route of administration. Participants are required to have used MA by the IV or smoked route to avoid exposing participants to drugs by routes of administration that produce more intensive interoceptive effects than usually used by the participants. Prior experience with smoked MA is allowed (rather than restricting the population to those with experience with IV MA) because smoked MA reaches brain sites of action as rapidly as does intravenously administered MA and smoked MA produces effects that are comparable to IV MA. Speed of administration (and rate of delivery to brain) of stimulant drugs likely impacts subjective and cardiovascular effects, so smoked and intravenously administered MA produce similar subjective effects (22-26).
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael Debakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Doxazosin as a Potential Treatment for Methamphetamine Dependence
The purpose of the study is to asses the potential interactions between methamphetamine and doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of methamphetamine in a human laboratory study.
The primary objective is to determine the safety of treatment with doxazosin in methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of methamphetamine and a placebo dose during treatment with doxazosin.
The secondary objective is to determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo
Read the detailed description
Purpose:
To determine the effects of treatment with doxazosin, compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
Secondary aims are to clarify the genetics of substance abuse, potentially leading to improved methods to diagnosis those at risk and to help develop better therapeutic interventions and to develop a new saliva-based test for the detection and measurement of drugs of abuse.
Design/Procedure:
Twenty non-treatment-seeking methamphetamine-dependent volunteers will complete procedures during treatment with placebo and study medication, in random order, using a within-subjects, double-blind, placebo-controlled design. There will be a two week period between each phase. The dose of doxazosin needed to alter the effects of methamphetamine is unknown and preclinical animal studies have not been conducted. Because of this, initially the investigators will study the effects of a low dose of doxazosin (4mg daily) compared to placebo daily. Methamphetamine (0, 10, and 30mg, smoked) will be administered during treatment with 4mg doxazosin/placebo. Methamphetamine will be administered in ascending dose (10mg followed by 20mg) with the 0mg dose randomly interspersed to maintain the blind. Cardiovascular measures and subjective effects ratings will be assessed following methamphetamine administration.
Participants will be monitored for stability on days 11 and 12 and discharged from the hospital on day 13.
If 4mg doxazosin treatment is well tolerated but is not associated with alterations in the effects of methamphetamine, a second group of subjects will be studied using the same sample size. Treatment will begin at 1mg and increased by 1mg increments every three days until 8mg is reached. Placebo will be dosed identically. All study procedures will be identical as described above.
- Conditions
- Substance-Related Disorders
- Being tested
- Sugar Pill, Doxazosin
- Keywords
- Methamphetamine, Dependence
- 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.
Sugar PillDrug
The administration of a sugar pill
DoxazosinDrug
The administration of the Doxazosin medication
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Sugar Pill |
| Doxazosin | Active comparator | Not described Receives: Drug: Doxazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure, change from baseline
Measured: -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing
heart rate, change from baseline
Measured: -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing
Secondary outcomes (1)
subjective effects of methamphetamine or placebo, change from baseline
Subjective effects are drug effects including euphoria, desire, anxiety, stimulation
Measured: -15 min, 5 min, 15 min, 30 min, 45 min and 60 min after MA dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Thomas Newton, National Institute on Drug Abuse (NIDA)
- Investigators
- Thomas F Newton, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785393
- Sponsor's protocol ID
- H-26957
- Other IDs
- DPMC, P50DA018197
- Acronym
- DOX-Meth
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxazosin as a Potential Treatment for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT02785393
- Acronym / sponsor ID
- DOX-Meth / H-26957
- Conditions
- Substance-Related Disorders
- Keywords
- Methamphetamine, Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 May 2016 (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.
The purpose of the study is to asses the potential interactions between methamphetamine and doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of methamphetamine in a human laboratory study.
The primary objective is to determine the safety of treatment with doxazosin in methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of methamphetamine and a placebo dose during treatment with doxazosin.
The secondary objective is to determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo
Detailed description
Purpose:
To determine the effects of treatment with doxazosin, compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
Secondary aims are to clarify the genetics of substance abuse, potentially leading to improved methods to diagnosis those at risk and to help develop better therapeutic interventions and to develop a new saliva-based test for the detection and measurement of drugs of abuse.
Design/Procedure:
Twenty non-treatment-seeking methamphetamine-dependent volunteers will complete procedures during treatment with placebo and study medication, in random order, using a within-subjects, double-blind, placebo-controlled design. There will be a two week period between each phase. The dose of doxazosin needed to alter the effects of methamphetamine is unknown and preclinical animal studies have not been conducted. Because of this, initially the investigators will study the effects of a low dose of doxazosin (4mg daily) compared to placebo daily. Methamphetamine (0, 10, and 30mg, smoked) will be administered during treatment with 4mg doxazosin/placebo. Methamphetamine will be administered in ascending dose (10mg followed by 20mg) with the 0mg dose randomly interspersed to maintain the blind. Cardiovascular measures and subjective effects ratings will be assessed following methamphetamine administration.
Participants will be monitored for stability on days 11 and 12 and discharged from the hospital on day 13.
If 4mg doxazosin treatment is well tolerated but is not associated with alterations in the effects of methamphetamine, a second group of subjects will be studied using the same sample size. Treatment will begin at 1mg and increased by 1mg increments every three days until 8mg is reached. Placebo will be dosed identically. All study procedures will be identical as described above.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: Sugar Pill |
| Doxazosin | Active comparator | Drug: Doxazosin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be English-speaking volunteers who are not seeking treatment at the time of the study
- Be between 18-55 years of age
- Meet DSM-IV TR criteria for methamphetamine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most methamphetamine users smoke cigarettes.
- Have a self-reported history of using methamphetamine by the smoked or IV route
- Have vital signs as follows: supine blood pressure > 100/65 mm Hg, a seated blood pressure of > 90/60 mm Hg, and an orthostatic change < 20 mm Hg systolic or <10 mm Hg diastolic on standing. To ensure that subjects will not be at risk from methamphetamine, the resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.
Key exclusion criteria (16 listed)
- Meet DSM IV TR criteria for dependence on drugs other than methamphetamine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury
- Have any previous medically adverse reaction to methamphetamine, including loss of consciousness, chest pain, or epileptic seizure
- Have neurological or psychiatric disorders, such as:
- Have evidence of clinically significant heart disease or hypertension, as determined by the PI
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 |
|---|---|---|
| Sugar PillThe administration of a sugar pill | Drug | Sugar Pill |
| DoxazosinThe administration of the Doxazosin medication | Drug | Doxazosin |
Primary outcome
blood pressure, change from baseline
Time frame: -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing
heart rate, change from baseline
Time frame: -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing
1 secondary outcome
subjective effects of methamphetamine or placebo, change from baseline
Time frame: -15 min, 5 min, 15 min, 30 min, 45 min and 60 min after MA dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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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.
Thomas F Newton, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sugar Pill and Doxazosin in people with Substance-Related Disorders, run by Baylor College of Medicine 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 8 inclusion and 16 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 29 Sep 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood pressure, change from baseline (time frame: -15 min, 15 min, 30 min, 45 min, 60 min post-MA dosing). The study lists 2 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 29 Sep 2016.