Cocaine AddictionPhase 1NCT01062945
The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine
A Phase 1 study testing Doxazosin in people with Cocaine Addiction and Cocaine Abuse, 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 intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Addiction, Cocaine Abuse, Cocaine Dependence
- What is being tested?
- Doxazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2011
- 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
- No healthy volunteers
- 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 cocaine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most cocaine users smoke cigarettes.
- Have a self-reported history of using cocaine 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 < 150/90 mm Hg, and an orthostatic change < 20 mm Hg systolic or <10 mm Hg diastolic on standing. Resting pulse must be < 90 bpm.
- 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 cocaine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to cocaine, 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; 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.
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- 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.
- Subject Selection Criteria Rationale for Route of Administration:
- Participants are required to have used cocaine 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 cocaine is allowed (rather than restricting the population to those with experience with IV cocaine) because smoked cocaine reaches brain sites of action as rapidly as does intravenously administered cocaine and smoked cocaine produces effects that are comparable to IV cocaine. Speed of administration (and rate of delivery to brain) of stimulant drugs likely impacts subjective and cardiovascular effects, so smoked and intravenously administered cocaine produce similar subjective effects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael Debakey VA Medical Center
Houston, Texas, 77030
About this study
The purpose of the study is to asses the potential interactions between intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study.
Read the detailed description
Primary Objective: The primary objective is to determine the safety of treatment with doxazosin in cocaine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose during treatment with doxazosin.
Secondary Objectives: To evaluate the effect of doxazosin on the pharmacokinetics of intravenously administered cocaine; To determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of cocaine or placebo.
- Conditions
- Cocaine Addiction, Cocaine Abuse, Cocaine Dependence, Substance Abuse
- Being tested
- Placebo, Doxazosin
- Keywords
- Cocaine, Doxazosin
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
Matching administration of a placebo pill.
DoxazosinDrug
Also called Cardura
The dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 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.
The effects of treatment with doxazosin on cardiovascular effects after administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose.
Blood pressure (resting and orthostatic) will be assessed daily prior to dosing. Heart rate, EKG, and blood pressure will be recorded throughout and after experimental sessions using an automatic monitoring system. Participants will be monitored for stability on days 11 and 12 and discharged from the hospital on day 13.
Secondary outcomes (1)
The effects of treatment with doxazosin, as compared to placebo, on subjective measures produced by administration of cocaine or placebo.
Visual-analogue scale ratings of "any cocaine effect", "high", "good effects", "bad effects", "like cocaine", "desire cocaine", "depressed", "anxious", "stimulated", and "if you had access to cocaine right now, how likely would you be to use it?" will be collected at -15 min, 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min after cocaine dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine AddictionStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 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, Baylor College of Medicine
- Investigators
- Thomas Newton, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062945
- Sponsor's protocol ID
- H-25442
- Other IDs
- P50DA018197, DPMC
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2010
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newton TF, De La Garza R 2nd, Brown G, Kosten TR, Mahoney JJ 3rd, Haile CN. Noradrenergic alpha(1) receptor antagonist treatment attenuates positive subjective effects of cocaine in humans: a randomized trial. PLoS One. 2012;7(2):e30854. doi: 10.1371/journal.pone.0030854. Epub 2012 Feb 3.
PubMed 22319592
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine
- ClinicalTrials.gov ID
- NCT01062945
- Acronym / sponsor ID
- H-25442
- Conditions
- Cocaine Addiction, Cocaine Abuse, Cocaine Dependence, Substance Abuse
- Keywords
- Cocaine, Doxazosin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Feb 2010 (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 intravenous cocaine and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in a human laboratory study.
Detailed description
Primary Objective: The primary objective is to determine the safety of treatment with doxazosin in cocaine-dependent volunteers by examining hemodynamic and subjective effects of administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose during treatment with doxazosin.
Secondary Objectives: To evaluate the effect of doxazosin on the pharmacokinetics of intravenously administered cocaine; To determine effects of treatment with doxazosin, as compared to placebo, on subjective effects produced by administration of cocaine or placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Doxazosin | Active comparator | Drug: Doxazosin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not 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 cocaine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most cocaine users smoke cigarettes.
- Have a self-reported history of using cocaine 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 < 150/90 mm Hg, and an orthostatic change < 20 mm Hg systolic or <10 mm Hg diastolic on standing. Resting pulse must be < 90 bpm.
Key exclusion criteria (14 listed)
- Meet DSM-IV TR criteria for dependence on drugs other than cocaine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to cocaine, 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; 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.
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 |
|---|---|---|
| PlaceboAlso: Sugar pillMatching administration of a placebo pill. | Drug | Placebo |
| DoxazosinAlso: CarduraThe dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12. | Drug | Doxazosin |
Primary outcome
The effects of treatment with doxazosin on cardiovascular effects after administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose.
Blood pressure (resting and orthostatic) will be assessed daily prior to dosing. Heart rate, EKG, and blood pressure will be recorded throughout and after experimental sessions using an automatic monitoring system. Participants will be monitored for stability on days 11 and 12 and discharged from the hospital on day 13.
1 secondary outcome
The effects of treatment with doxazosin, as compared to placebo, on subjective measures produced by administration of cocaine or placebo.
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 27 Jul 2012.
- Derived from this study: PubMed 22319592Newton TF, De La Garza R 2nd, Brown G, Kosten TR, Mahoney JJ 3rd, Haile CN. Noradrenergic alpha(1) receptor antagonist treatment attenuates positive subjective effects of cocaine in humans: a randomized trial. PLoS One. 2012;7(2):e30854. doi: 10.1371/journal.pone.0030854. Epub 2012 Feb 3.
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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 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 Doxazosin in people with Cocaine Addiction and Cocaine Abuse, 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 14 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 27 Jul 2012. 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?
The effects of treatment with doxazosin on cardiovascular effects after administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01062945, which also lists 1 linked publication.
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 27 Jul 2012.