SmokingPhase 1/2NCT00494728
Smoking Cessation for Depressed Smokers
A Phase 1/2 study testing Smoking Cessation Treatment, Nicotine Replacement Therapy and CBASP in people with Smoking and Depression, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Primary Aim: To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Depression
- What is being tested?
- Smoking Cessation Treatment, Nicotine Replacement Therapy and CBASP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2007to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently meeting DSM-IV criteria for major depressive disorder, recurrent; or major depressive disorder, recurrent, in partial remission; or major depressive disorder, single episode with a duration of 2 years or more; or; dysthymic disorder.
- Score greater than or equal to 8 on the PHQ at baseline
- Age greater than or equal to 16
- Smoking greater than or equal to 5 cigarettes per day
- Willing to set a quit date within 6 weeks of baseline
- English speaking and have a telephone
- Willing to attend all sessions
- Willing to provide informed consent and agree to all assessments and study procedures
Who cannot join
- History of psychotic or bipolar disorder
- Current psychotherapy
- Current use of antidepressant
- Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
- Involvement in any smoking cessation activities
- Current use of nicotine replacement therapy
Show all 11Show fewer
- Known health or other complications that would adversely affect attendance
- Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to secondary psychiatric disorders that place participant at risk for harm or require immediate treatment
- Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
- Medical contraindications for use of nicotine patch, including uncontrolled heart disease, history of severe hypersensitivity to nicotine replacement products, or currently pregnant or lactating
- 11) History of current medical condition, or any other factor that, in the judgment of the principal investigator, would likely preclude completion of study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Smoking Cessation Intervention for Depressed Smokers: Treatment Development
Objectives:
Primary Aim:
Read more
To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to:
- Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence
Secondary Aims:
- To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and;
- That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment.
- To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and:
- To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.
Read the detailed description
During the session today, you will be asked to complete 8-9 questionnaires about smoking history, health status, current medications you are taking, your confidence in quitting smoking, symptoms of nicotine dependence and withdrawal, symptoms of depression, negative experiences during childhood, and your thoughts and feelings about work and the quality of your relationships with others. In total, the questionnaires should take about 30-45 minutes to complete. You will also blow into a machine that measures the amount of carbon monoxide in your blood (a breath test). This visit may last 1 ½ to 2 hours.
Following the session today, you will be provided with information on the results of the screening tests you completed at BCM to see whether you have a current depressive disorder or any other psychiatric disorders. You will be provided with an opportunity to discuss this information with the investigators.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. If you are assigned to Group 1, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with mood management counseling to help you develop interpersonal (communication) coping skills to help with depression and negative moods that may affect your ability to quit smoking. If you are assigned to Group 2, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with education on the health-related effects of smoking. Participants in both groups will receive nicotine patches.
During the 5 weeks after the visit, you will have six (6) 70-minute counseling sessions.
If you are in Group 1, you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned. You will receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations. You will be encouraged to use these skills between sessions. You will also receive counseling to help you identify situations where you interact with others that may cause negative moods. You will be taught interpersonal coping skills to help decrease depression and negative moods and to increase your ability to quit smoking and not start again. You will be given homework assignments that will help you practice these skills between sessions.
If you are in Group 2, you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned. You will also receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations. You will be encouraged to use these skills between sessions. You will also receive information about health issues related to smoking and you will have the opportunity to discuss this information with your counselor.
Before or after each of the counseling sessions, you will fill out 2-3 questionnaires on mood and smoking behavior and have a breath test. You will be asked to fill out 5-6 questionnaires on withdrawal symptoms, confidence in quitting smoking, your thoughts and feelings about work, and the quality of your relationships with others. In total, it will should about 30-45 minutes to fill out the questionnaires at each visit. Each of these visits will take a total of about 1 hour and 40 minutes to 1 hour and 55 minutes.
The date to quit smoking will be scheduled for about 5 weeks after your first visit. As part of your counseling sessions, you will be provided with counseling to help you develop a plan to quit and to set a quit date. You will be given the nicotine patches starting on the quit date. You will be asked to wear the nicotine patches on the upper area of your body for 24 hours each day.
Following the quit date, you will attend six (6) more 70-minute counseling sessions. You will also attend 2 additional visits at 3 months and 6 months from your quit date. At each of these visits, you will be asked to fill out 2-3 questionnaires on mood and smoking behavior and to provide a breath test to measure the amount of carbon monoxide in your blood. You will be asked questions about symptoms you may be having and the medications you are taking. You will be asked to fill out 5-6 questionnaires on withdrawal symptoms, confidence in quitting smoking, and the quality of your relationships with others at some of these visits. If you are unable to attend your end-of-treatment, 3-month or 6-month visits, you may be asked to provide a saliva sample to measure the amount of cotinine in your blood, a chemical produced by the breakdown of nicotine during smoking. This sample will be taken using a dental roll (cotton swab) placed in the mouth for several minutes to absorb saliva. At the 3-month and 6-month follow-up visits, you will be also asked questions about any current problems with depression.
At the last treatment visit (Visit 12) and at the 3-month and 6-month follow-up visits, if you are still smoking, you will be provided with information on where you can receive additional help to quit smoking. If you continue to have a current depressive disorder, you will be provided with additional information about this disorder, and you will be provided with information on where you can receive treatment for your depressive disorder. The investigators will provide a referral for treatment if you wish to receive treatment for your depressive disorder at that time.
Each of the counseling visits will be videotaped. In addition, the first visit and the visits at 3 and 6 months may also be videotaped. The videotapes will be erased within 1 year after you complete this study. The videotapes will be used to help the investigators make sure that the counselors are following the correct therapy procedures and may be used in future studies to help the investigators better understand the mood management and health education treatments. No one but the study investigators, study staff, and consultants (those who review and rate how well the study therapists follow therapy procedures) will be allowed to view the tapes. Your identity will be kept strictly confidential.
So that the study researchers can keep in contact with you throughout the study and over the long period of time between your end of treatment visit and the 3- and 6- month follow-up visits, you will be asked at the baseline visit to provide the name and address of 2 contacts (family members/friends) that you feel confident would have updated contact information on you.
Your participation in this study will end after the 6-month follow-up visit.
This is an investigational study. The nicotine patches are FDA approved for use in adults age 18 and older and commercially available. Up to 202 people will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Smoking, Depression
- Being tested
- Smoking Cessation Treatment, Nicotine Replacement Therapy, CBASP
- Keywords
- Smoking, Depression, Major Depressive Disorder, Cognitive Behavioral Analysis System of Psychotherapy, Smoking Cessation Treatment, Nicotine Replacement Therapy, Nicotine Patch, CBASP, MDD
- Medical subject headings
- Smoking, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation TreatmentBehavioural
12 60-minute individual sessions of standard smoking cessation treatment.
Nicotine Replacement TherapyDrug
21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.
CBASPBehavioural
Also called Cognitive Behavioral Analysis System of Psychotherapy
Individual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| CBASP + ST | Other | Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST) Receives: Behavioral: Smoking Cessation Treatment; Drug: Nicotine Replacement Therapy; Behavioral: CBASP |
| ST | Other | Smoking Cessation Treatment (ST) Receives: Behavioral: Smoking Cessation Treatment; Drug: Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Rates
Measured: Approximately each 12 weeks following end of treatment (about 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start28 Jun 2007
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jan Blalock, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494728
- Sponsor's protocol ID
- 2006-0351
- Other IDs
- NCI-2012-02097, 1R01MH076776-01A1, 1R01MH087692
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2007
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Intervention for Depressed Smokers: Treatment Development
- ClinicalTrials.gov ID
- NCT00494728
- Acronym / sponsor ID
- 2006-0351
- Conditions
- Smoking, Depression
- Keywords
- Smoking, Depression, Major Depressive Disorder, Cognitive Behavioral Analysis System of Psychotherapy, Smoking Cessation Treatment, Nicotine Replacement Therapy, Nicotine Patch, CBASP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Jun 2007 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jul 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.
Objectives:
Primary Aim:
To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to:
- Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence
Secondary Aims:
- To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and;
- That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment.
- To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and:
- To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.
Detailed description
During the session today, you will be asked to complete 8-9 questionnaires about smoking history, health status, current medications you are taking, your confidence in quitting smoking, symptoms of nicotine dependence and withdrawal, symptoms of depression, negative experiences during childhood, and your thoughts and feelings about work and the quality of your relationships with others. In total, the questionnaires should take about 30-45 minutes to complete. You will also blow into a machine that measures the amount of carbon monoxide in your blood (a breath test). This visit may last 1 ½ to 2 hours.
Following the session today, you will be provided with information on the results of the screening tests you completed at BCM to see whether you have a current depressive disorder or any other psychiatric disorders. You will be provided with an opportunity to discuss this information with the investigators.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. If you are assigned to Group 1, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with mood management counseling to help you develop interpersonal (communication) coping skills to help with depression and negative moods that may affect your ability to quit smoking. If you are assigned to Group 2, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with education on the health-related effects of smoking. Participants in both groups will receive nicotine patches.
During the 5 weeks after the visit, you will have six (6) 70-minute counseling sessions.
If you are in Group 1, you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned. You will receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations. You will be encouraged to use these skills between sessions. You will also receive counseling to help you identify situations where you interact with others that may cause negative moods. You will be taught interpersonal coping skills to help decrease depression and negative moods and to increase your ability to quit smoking and not start again. You will be given homework assignments that will help you practice these skills between sessions.
If you are in Group 2, you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned. You will also receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations. You will be encouraged to use these skills between sessions. You will also receive information about health issues related to smoking and you will have the opportunity to discuss this information with your counselor.
Before or after each of the counseling sessions, you will fill out 2-3 questionnaires on mood and smoking behavior and have a breath test. You will be asked to fill out 5-6 questionnaires on withdrawal symptoms, confidence in quitting smoking, your thoughts and feelings about work, and the quality of your relationships with others. In total, it will should about 30-45 minutes to fill out the questionnaires at each visit. Each of these visits will take a total of about 1 hour and 40 minutes to 1 hour and 55 minutes.
The date to quit smoking will be scheduled for about 5 weeks after your first visit. As part of your counseling sessions, you will be provided with counseling to help you develop a plan to quit and to set a quit date. You will be given the nicotine patches starting on the quit date. You will be asked to wear the nicotine patches on the upper area of your body for 24 hours each day.
Following the quit date, you will attend six (6) more 70-minute counseling sessions. You will also attend 2 additional visits at 3 months and 6 months from your quit date. At each of these visits, you will be asked to fill out 2-3 questionnaires on mood and smoking behavior and to provide a breath test to measure the amount of carbon monoxide in your blood. You will be asked questions about symptoms you may be having and the medications you are taking. You will be asked to fill out 5-6 questionnaires on withdrawal symptoms, confidence in quitting smoking, and the quality of your relationships with others at some of these visits. If you are unable to attend your end-of-treatment, 3-month or 6-month visits, you may be asked to provide a saliva sample to measure the amount of cotinine in your blood, a chemical produced by the breakdown of nicotine during smoking. This sample will be taken using a dental roll (cotton swab) placed in the mouth for several minutes to absorb saliva. At the 3-month and 6-month follow-up visits, you will be also asked questions about any current problems with depression.
At the last treatment visit (Visit 12) and at the 3-month and 6-month follow-up visits, if you are still smoking, you will be provided with information on where you can receive additional help to quit smoking. If you continue to have a current depressive disorder, you will be provided with additional information about this disorder, and you will be provided with information on where you can receive treatment for your depressive disorder. The investigators will provide a referral for treatment if you wish to receive treatment for your depressive disorder at that time.
Each of the counseling visits will be videotaped. In addition, the first visit and the visits at 3 and 6 months may also be videotaped. The videotapes will be erased within 1 year after you complete this study. The videotapes will be used to help the investigators make sure that the counselors are following the correct therapy procedures and may be used in future studies to help the investigators better understand the mood management and health education treatments. No one but the study investigators, study staff, and consultants (those who review and rate how well the study therapists follow therapy procedures) will be allowed to view the tapes. Your identity will be kept strictly confidential.
So that the study researchers can keep in contact with you throughout the study and over the long period of time between your end of treatment visit and the 3- and 6- month follow-up visits, you will be asked at the baseline visit to provide the name and address of 2 contacts (family members/friends) that you feel confident would have updated contact information on you.
Your participation in this study will end after the 6-month follow-up visit.
This is an investigational study. The nicotine patches are FDA approved for use in adults age 18 and older and commercially available. Up to 202 people will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBASP + ST | Other | Behavioral: Smoking Cessation Treatment, Drug: Nicotine Replacement Therapy, Behavioral: CBASPCognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST) |
| ST | Other | Behavioral: Smoking Cessation Treatment, Drug: Nicotine Replacement TherapySmoking Cessation Treatment (ST) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Currently meeting DSM-IV criteria for major depressive disorder, recurrent; or major depressive disorder, recurrent, in partial remission; or major depressive disorder, single episode with a duration of 2 years or more; or; dysthymic disorder.
- Score greater than or equal to 8 on the PHQ at baseline
- Age greater than or equal to 16
- Smoking greater than or equal to 5 cigarettes per day
- Willing to set a quit date within 6 weeks of baseline
Key exclusion criteria (11 listed)
- History of psychotic or bipolar disorder
- Current psychotherapy
- Current use of antidepressant
- Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
- Involvement in any smoking cessation activities
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 |
|---|---|---|
| Smoking Cessation Treatment12 60-minute individual sessions of standard smoking cessation treatment. | Behavioural | CBASP + ST, ST |
| Nicotine Replacement Therapy21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks. | Drug | CBASP + ST, ST |
| CBASPAlso: Cognitive Behavioral Analysis System of PsychotherapyIndividual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking. | Behavioural | CBASP + ST |
Primary outcome
Abstinence Rates
Time frame: Approximately each 12 weeks following end of treatment (about 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jan Blalock, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Smoking Cessation Treatment, Nicotine Replacement Therapy and CBASP in people with Smoking and Depression, run by M.D. Anderson Cancer Center 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 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Abstinence Rates (time frame: Approximately each 12 weeks following end of treatment (about 6 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 15 Jun 2026.