Cocaine DependencePhase 1NCT00880997
The Efficacy of Doxazosin for Cocaine Users
A Phase 1 study testing Doxazosin in people with Cocaine Dependence, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity of Dependence Scale
- If female, willing to use contraception throughout the study
Who cannot join
- Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or tobacco
- Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
- Current suicidal or homicidal ideation
- Current use of a prescribed psychotropic medication that cannot be discontinued
- History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure or low blood pressure
- High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable
- Currently taking metronidazole or clotrimazole
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study
Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.
Read the detailed description
The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.
This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.
Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:
- Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
- Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
Both groups will be tapered off doxazosin or placebo over study weeks 14-17.
- Conditions
- Cocaine Dependence
- Being tested
- Doxazosin, Placebo
- Keywords
- Cocaine Dependence, Substance Related Disorders
- 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.
DoxazosinDrug
Also called Cardura (Doxazosin Mesylate)
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
- Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
- Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17.
PlaceboOther
Also called sugarpills ( Capsules)
Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.
| Study group | Role | What they receive |
|---|---|---|
| Doxazosin | Experimental | Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
Both groups were tapered off doxazosin or placebo over study weeks 14-17. Receives: Drug: Doxazosin |
| placebo | Placebo comparator | A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Negative Urines
cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
Measured: throughout the study - up to 17 weeks
Secondary outcomes (3)
Weeks of Abstinence
Percentage of participants achieving 2 or more consecutive weeks of abstinence
Measured: throughout the study - up to 17 weeks
# of Participants That Completed the Study
Retention
Measured: throughout the study - up to 17 weeks
Adverse Events
Measured: throughout study - upto 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionDec 2011
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 Cocaine DependenceStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 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 R. Kosten, MD, Baylor College of Medicine
- Investigators
- Thomas R Kosten, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880997
- Sponsor's protocol ID
- NIDA-18197-4
- Other IDs
- P50DA018197-04, DPMC
- Status last verified
- Aug 2019
- First submitted
- 13 Apr 2009
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxazosin, An Alpha-1 Adrenergic Antagonist, for Cocaine Dependence: Pilot Study
- ClinicalTrials.gov ID
- NCT00880997
- Acronym / sponsor ID
- NIDA-18197-4
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine Dependence, Substance Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.
Detailed description
The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.
This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.
Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:
- Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
- Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
Both groups will be tapered off doxazosin or placebo over study weeks 14-17.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxazosin | Experimental | Drug: DoxazosinMedication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: 1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group) 2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group) Both groups were tapered off doxazosin or placebo over study weeks 14-17. |
| placebo | Placebo comparator | Other: PlaceboA sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity of Dependence Scale
- If female, willing to use contraception throughout the study
Key exclusion criteria (8 listed)
- Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or tobacco
- Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
- Current suicidal or homicidal ideation
- Current use of a prescribed psychotropic medication that cannot be discontinued
- History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure or low blood pressure
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 |
|---|---|---|
| DoxazosinAlso: Cardura (Doxazosin Mesylate)Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: 1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group) 2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group) Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17. | Drug | Doxazosin |
| PlaceboAlso: sugarpills ( Capsules)Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication. | Other | placebo |
Primary outcome
Cocaine Negative Urines
Time frame: throughout the study - up to 17 weeks
cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
3 secondary outcomes
Weeks of Abstinence
Time frame: throughout the study - up to 17 weeks
# of Participants That Completed the Study
Time frame: throughout the study - up to 17 weeks
Adverse Events
Time frame: throughout study - upto 17 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 R Kosten, 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 Dependence, 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 2 inclusion and 8 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 22 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2019). 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?
Cocaine Negative Urines (time frame: throughout the study - up to 17 weeks). 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 22 Aug 2019.