Cigarette SmokingPhase 2NCT00937235
Treatment of Smoking Among Individuals With PTSD
A Phase 2 study testing Varenicline, Medication Management Counseling and Prolonged Exposure in people with Cigarette Smoking and Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder
- What is being tested?
- Varenicline, Medication Management Counseling and Prolonged Exposure
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
- Current diagnosis of chronic PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms (PSS-I >= 20)
- Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
- Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
- If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
- Demonstrate the capacity to provide informed consent;
- Speak and read English.
Who cannot join
- History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
- Current and continuing intimate relationship with a physically or sexually abusive partner;
- Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
- Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
- Current or past history of psychosis (bipolar disorder or schizophrenia);
- History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
- Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
About this study
Official title: Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
- Conditions
- Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder, Tobacco Use Disorder
- Being tested
- Varenicline, Medication Management Counseling, Prolonged Exposure
- Keywords
- Smoking Cessation, Anxiety, Behavior Therapy, Varenicline
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Stress Disorders, Post-Traumatic, Smoking Cessation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
1 mg tablets, orally, twice daily x 12 weeks
Medication Management CounselingBehavioural
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Prolonged ExposureBehavioural
Also called Cognitive-Behavioral Therapy
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment | Experimental | Prolonged Exposure + Varenicline + Medication Management Counseling Receives: Drug: Varenicline; Behavioral: Medication Management Counseling; Behavioral: Prolonged Exposure |
| Varenicline | Active comparator | Varenicline + Medication Management Counseling Receives: Drug: Varenicline; Behavioral: Medication Management Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.
Measured: At 3-month follow-up (6-month post-quit day)
Secondary outcomes (7)
Blood Serum Cotinine
Level of cotinine in blood
Measured: At end of 3-month follow-up
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD.
Measured: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD.
Measured: 3-month follow-up
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression.
Measured: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression.
Measured: 3-month follow-up
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
Measured: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2015
- Study completionDec 2015
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Edna B Foa, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937235
- Sponsor's protocol ID
- R01DA023507
- Other IDs
- R01DA023507
- Status last verified
- Oct 2017
- First submitted
- 8 Jul 2009
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT00937235
- Acronym / sponsor ID
- R01DA023507
- Conditions
- Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder, Tobacco Use Disorder
- Keywords
- Smoking Cessation, Anxiety, Behavior Therapy, Varenicline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 7 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Treatment | Experimental | Drug: Varenicline, Behavioral: Medication Management Counseling, Behavioral: Prolonged ExposureProlonged Exposure + Varenicline + Medication Management Counseling |
| Varenicline | Active comparator | Drug: Varenicline, Behavioral: Medication Management CounselingVarenicline + Medication Management Counseling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
- Current diagnosis of chronic PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms (PSS-I >= 20)
- Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
- Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
- If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
Key exclusion criteria (7 listed)
- History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
- Current and continuing intimate relationship with a physically or sexually abusive partner;
- Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
- Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
- Current or past history of psychosis (bipolar disorder or schizophrenia);
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 |
|---|---|---|
| VareniclineAlso: Chantix1 mg tablets, orally, twice daily x 12 weeks | Drug | Integrated Treatment, Varenicline |
| Medication Management Counseling15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation | Behavioural | Integrated Treatment, Varenicline |
| Prolonged ExposureAlso: Cognitive-Behavioral Therapy75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders | Behavioural | Integrated Treatment |
Primary outcome
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Time frame: At 3-month follow-up (6-month post-quit day)
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.
7 secondary outcomes
Blood Serum Cotinine
Time frame: At end of 3-month follow-up
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Time frame: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
Time frame: 3-month follow-up
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Time frame: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
Time frame: 3-month follow-up
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Time frame: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Time frame: 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Center for the Treatment and Study of AnxietyLink 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.
Edna B Foa, Ph.D. principal investigator
University of Pennsylvania
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 Varenicline, Medication Management Counseling and Prolonged Exposure in people with Cigarette Smoking and Nicotine Dependence, run by University of Pennsylvania 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 7 inclusion and 7 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 14 Nov 2017. 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 7 Sep 2017). 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?
Number of Participants With 7-day Point Prevalence Smoking Abstinence (time frame: At 3-month follow-up (6-month post-quit day)). 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 14 Nov 2017.