Cigarette SmokingPhase 2NCT00500877
Mood Management Phone Counseling in Smoking Cessation
A Phase 2 study testing Mood Management Phone Counseling for Smoking Cessation in people with Cigarette Smoking, run by Butler Hospital at 1 site in United States.
Trial summary
Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Mood Management Phone Counseling for Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2008
- Phase
- Phase 2
- 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
- history of two or more past episodes of depression
- regular cigarette smoker for at least one year
- currently smoking 10 or more cigarettes each day
- want to quit smoking
Who cannot join
- Current Depressive Episode
- Current Alcohol of Substance abuse
- Pregnant, planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.
Read the detailed description
Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.
- Conditions
- Cigarette Smoking
- Being tested
- Mood Management Phone Counseling for Smoking Cessation
- Keywords
- Smoking cessation, Phone Counseling
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood Management Phone Counseling for Smoking CessationBehavioural
Phone counseling addressed mood management and smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Mood Management Phone counseling | Active comparator | Mood management phone counseling for smoking cessation Receives: Behavioral: Mood Management Phone Counseling for Smoking Cessation |
| Phone Counseling Standard | Placebo comparator | Phone counseling standard Receives: Behavioral: Mood Management Phone Counseling for Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David Strong, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500877
- Sponsor's protocol ID
- 1R01DA017947
- Other IDs
- R01DA017947
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2007
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Management Phone Counseling in Smoking Cessation
- ClinicalTrials.gov ID
- NCT00500877
- Acronym / sponsor ID
- 1R01DA017947
- Conditions
- Cigarette Smoking
- Keywords
- Smoking cessation, Phone Counseling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 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.
Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.
Detailed description
Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mood Management Phone counseling | Active comparator | Behavioral: Mood Management Phone Counseling for Smoking CessationMood management phone counseling for smoking cessation |
| Phone Counseling Standard | Placebo comparator | Behavioral: Mood Management Phone Counseling for Smoking CessationPhone counseling standard |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of two or more past episodes of depression
- regular cigarette smoker for at least one year
- currently smoking 10 or more cigarettes each day
- want to quit smoking
Key exclusion criteria (3 listed)
- Current Depressive Episode
- Current Alcohol of Substance abuse
- Pregnant, planning to become pregnant
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 |
|---|---|---|
| Mood Management Phone Counseling for Smoking CessationPhone counseling addressed mood management and smoking cessation | Behavioural | Mood Management Phone counseling, Phone Counseling Standard |
Primary outcome
Smoking Abstinence
Time frame: 6 months
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 20 Jul 2016.
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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.
David Strong, Ph.D. principal investigator
Butler Hospital
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 Mood Management Phone Counseling for Smoking Cessation in people with Cigarette Smoking, run by Butler Hospital 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 4 inclusion and 3 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 20 Jul 2016. 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 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?
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?
Smoking Abstinence (time frame: 6 months). 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 20 Jul 2016.