Tobacco Use DisorderPhase 4NCT00781755
Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal
A Phase 4 study testing varenicline and Adaptation of Motivational Interviewing in people with Tobacco Use Disorder, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- varenicline and Adaptation of Motivational Interviewing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants for this study:
- Are between the ages 18-65 years of age
- Are daily cigarette smokers
- Have smoked a minimum of 10 cigarettes per day for at least one year
- Are confirmed smokers as verified by CO
- Have a psychiatric diagnosis of schizophrenia or schizoaffective disorder (any subtype) as determined by the SCID-IV. Participants must have received a stable dose of antipsychotic medication for at least 2 weeks prior to beginning the study. Patients receiving clozapine at 500 mg/day or more must also be receiving anti-seizure prophylaxis. Patients must be determined to be psychiatrically stable at baseline as established by standardized interview and medical review by psychiatrist.
Who cannot join
- Individuals who are not eligible to participate in this study include individuals with:
- Any serious or unstable medical problem in the last 6 months
- Severe renal impairment
- A history of clinically significant allergic reactions to nicotine agonist medications
- Current primary use of tobacco products other than cigarettes
- Breath alcohol level > 0.005 g/l at screening
Show all 14Show fewer
- Current substance abuse or dependence (besides nicotine)
- Current attempts to quit smoking using any method
- Designation as legally incompetent to sign the informed consent (i.e., have a guardian or have delegated power of attorney to another).
- Other exclusions are:
- Current use of medications that might affect the behavioral response to cigarette smoking, including transdermal nicotine or nicotine gum and bupropion - Inability to participate in the screening session due to severe psychosis, severe depression or suicidality, current mania, or an organic mental disorder such as dementia or delirium
- Presence of unstable psychiatric symptoms or clinical deterioration (i.e., unstable psychosis, homicidality, or suicidality) within the last month.
- Females of childbearing potential are eligible if not pregnant or nursing and if they practice effective contraception (oral, injectable, or implantable contraceptives; intrauterine device; or barrier method with spermicide).
- There currently are no known contraindications to the use of varenicline and no identified drug-drug interactions. However, reduced dosage of varenicline is recommended for individuals with severe renal impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Brockton Medical Center
Brockton, Massachusetts, 02301
About this study
Official title: Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks.
The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.
- Conditions
- Tobacco Use Disorder
- Being tested
- varenicline, Adaptation of Motivational Interviewing
- Keywords
- smoking cessation, varenicline, schizophrenia, serious mental illness, Nicotine addiction, Smoking Behavior
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Schizophrenia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
.5mg/day for 3 days then titrated to 1.0mg/day for 11 days. A total dosing regimen of 14 days.
Adaptation of Motivational InterviewingBehavioural
2 sessions of behavioral intervention designed to create ambivalence about quitting or plan for a quit attempt if the patient is ready.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | VAR-MI: This group will receive 1mg/day varenicline (titrated from .5mg/day) and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks. Receives: Drug: varenicline; Behavioral: Adaptation of Motivational Interviewing |
| 2 | Placebo comparator | PLA-MI: VAR-MI: This group will receive a daily placebo pill and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks. Receives: Behavioral: Adaptation of Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Smoking Urge and Withdrawal
Measured: 2 weeks
Secondary outcomes (2)
Smoking Status
Measured: 2 weeks
Mood Ratings
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
Why it stopped: Study design was altered such that a treatment component was removed through the VA IRB. We did not and will not begin this clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Investigators
- Gary B Kaplan, M.D., Principal investigator, VA Boston Healthcare SystemSuzy Bird Gulliver, Ph.D., Study chair, VISN 17 Center of Excellence for Research on Returning War VeteransBarbara W Kamholz, Ph.D., Study chair, VA Boston Healthcare SystemJames Levitt, M.D., Study chair, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781755
- Sponsor's protocol ID
- 1988
- Other IDs
- VABHS IRB Protocol #1988
- Status last verified
- Dec 2008
- First submitted
- 28 Oct 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal
- ClinicalTrials.gov ID
- NCT00781755
- Acronym / sponsor ID
- 1988
- Conditions
- Tobacco Use Disorder
- Keywords
- smoking cessation, varenicline, schizophrenia, serious mental illness, Nicotine addiction, Smoking Behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design was altered such that a treatment component was removed through the VA IRB. We did not and will not begin this clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- First posted
- 29 Oct 2008 (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.
This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks.
The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.
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 |
|---|---|---|
| 1 | Experimental | Drug: varenicline, Behavioral: Adaptation of Motivational InterviewingVAR-MI: This group will receive 1mg/day varenicline (titrated from .5mg/day) and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks. |
| 2 | Placebo comparator | Behavioral: Adaptation of Motivational InterviewingPLA-MI: VAR-MI: This group will receive a daily placebo pill and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are between the ages 18-65 years of age
- Are daily cigarette smokers
- Have smoked a minimum of 10 cigarettes per day for at least one year
- Are confirmed smokers as verified by CO
- Have a psychiatric diagnosis of schizophrenia or schizoaffective disorder (any subtype) as determined by the SCID-IV. Participants must have received a stable dose of antipsychotic medication for at least 2 weeks prior to beginning the study. Patients receiving clozapine at 500 mg/day or more must also be receiving anti-seizure prophylaxis. Patients must be determined to be psychiatrically stable at baseline as established by standardized interview and medical review by psychiatrist.
Key exclusion criteria (14 listed)
- Any serious or unstable medical problem in the last 6 months
- Severe renal impairment
- A history of clinically significant allergic reactions to nicotine agonist medications
- Current primary use of tobacco products other than cigarettes
- Breath alcohol level > 0.005 g/l at screening
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 |
|---|---|---|
| varenicline.5mg/day for 3 days then titrated to 1.0mg/day for 11 days. A total dosing regimen of 14 days. | Drug | 1 |
| Adaptation of Motivational Interviewing2 sessions of behavioral intervention designed to create ambivalence about quitting or plan for a quit attempt if the patient is ready. | Behavioural | 1, 2 |
Primary outcome
Reported Smoking Urge and Withdrawal
Time frame: 2 weeks
2 secondary outcomes
Smoking Status
Time frame: 2 weeks
Mood Ratings
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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.
Gary B Kaplan, M.D. principal investigator
VA Boston Healthcare System
Suzy Bird Gulliver, Ph.D. study chair
VISN 17 Center of Excellence for Research on Returning War Veterans
Barbara W Kamholz, Ph.D. study chair
VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing varenicline and Adaptation of Motivational Interviewing in people with Tobacco Use Disorder, run by VA Boston Healthcare System 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 6 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: withdrawn, as of the sponsor's last update on 4 Jun 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reported Smoking Urge and Withdrawal (time frame: 2 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 4 Jun 2015.