DepressionPhase 3NCT00018174
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
A Phase 3 study testing Fluoxetine and Behavioral group smoking cessation treatment in people with Depression and Smoking, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Smoking
- What is being tested?
- Fluoxetine and Behavioral group smoking cessation treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Jan 2005
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
- None will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
- All will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.
Who cannot join
- Subjects may not enter the trial if they:
- have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
- are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
- are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
- have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
- have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
Show all 14Show fewer
- have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
- are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
- are using nicotine replacements;
- are pregnant, lactating, or of childbearing potential;
- present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
- have a score greater than 14 on the 21-item Hamilton Depression Rating Scale or greater than 15 on the Beck Depression Inventory;
- have a history of seizures, mania or hypomania, or psychosis. Individuals with bipolar disorder, PTSD, or schizophrenia will be excluded because they might respond adversely to fluoxetine.
- Subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. Excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-3030
About this study
This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.
Read the detailed description
The aim of this research is to examine whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation for the smoker who lacks a history of depression, by randomizing smokers both with and without such a history to double-blind treatment with either 60 mg fluoxetine or placebo. The primary Depressive Episode Hypothesis states that the stress of quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive episode in vulnerable individuals. To the extent that episode onset can be prevented by prophylactic administration of antidepressant pharmacotherapy, smokers with a history of depression will show significantly higher abstinence rates when treated with fluoxetine than placebo, whereas no drug effect will be evident for history negative smokers who lack the depressive diathesis. An alternative generalized withdrawal hypothesis construes post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that occurs independently of depressive vulnerability, and predicts that fluoxetine, as compared to placebo, will uniformly improve cessation outcomes, regardless of whether smokers possess the diathesis for depression. Over period of four years, the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit date. Participants will be followed up monthly for 4 months after the end of treatment in order to assess the main study outcome; abstinence from smoking 6 months after the quit date.
- Conditions
- Depression, Smoking
- Being tested
- Fluoxetine, Behavioral group smoking cessation treatment, Placebo
- Keywords
- Depression, Fluoxetine, Nicotine dependence
- Medical subject headings
- Depression, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Behavioral group smoking cessation treatmentBehavioural
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fluoxetine; Behavioral: Behavioral group smoking cessation treatment |
| 2 | Placebo comparator | Not described Receives: Behavioral: Behavioral group smoking cessation treatment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
tobacco 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 posted5 Jul 2001 (estimated)
- Study startFeb 1998
- Primary completionJan 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Eli Lilly and Company
- Investigators
- Bonnie Spring, PhD, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018174
- Sponsor's protocol ID
- ADRD-011-97S
- Status last verified
- Feb 2009
- First submitted
- 3 Jul 2001
- Last updated
- 2 Mar 2009
- Results posted
- No
Publications
Spring B, Doran N, Pagoto S, McChargue D, Cook JW, Bailey K, Crayton J, Hedeker D. Fluoxetine, smoking, and history of major depression: A randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):85-94. doi: 10.1037/0022-006X.75.1.85.
PubMed 17295567Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
- ClinicalTrials.gov ID
- NCT00018174
- Acronym / sponsor ID
- ADRD-011-97S
- Conditions
- Depression, Smoking
- Keywords
- Depression, Fluoxetine, Nicotine dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 1998
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 5 Jul 2001 (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 project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.
Detailed description
The aim of this research is to examine whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation for the smoker who lacks a history of depression, by randomizing smokers both with and without such a history to double-blind treatment with either 60 mg fluoxetine or placebo. The primary Depressive Episode Hypothesis states that the stress of quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive episode in vulnerable individuals. To the extent that episode onset can be prevented by prophylactic administration of antidepressant pharmacotherapy, smokers with a history of depression will show significantly higher abstinence rates when treated with fluoxetine than placebo, whereas no drug effect will be evident for history negative smokers who lack the depressive diathesis. An alternative generalized withdrawal hypothesis construes post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that occurs independently of depressive vulnerability, and predicts that fluoxetine, as compared to placebo, will uniformly improve cessation outcomes, regardless of whether smokers possess the diathesis for depression. Over period of four years, the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit date. Participants will be followed up monthly for 4 months after the end of treatment in order to assess the main study outcome; abstinence from smoking 6 months after the quit date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluoxetine, Behavioral: Behavioral group smoking cessation treatment |
| 2 | Placebo comparator | Behavioral: Behavioral group smoking cessation treatment, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
- None will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
- All will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.
Key exclusion criteria (14 listed)
- have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
- are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
- are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
- have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
- have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
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 |
|---|---|---|
| Fluoxetine | Drug | 1 |
| Behavioral group smoking cessation treatment | Behavioural | 1, 2 |
| Placebo | Drug | 2 |
Primary outcome
tobacco 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 2 Mar 2009.
- Results publication: PubMed 17295567Spring B, Doran N, Pagoto S, McChargue D, Cook JW, Bailey K, Crayton J, Hedeker D. Fluoxetine, smoking, and history of major depression: A randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):85-94. doi: 10.1037/0022-006X.75.1.85.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
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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.
Bonnie Spring, PhD principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine and Behavioral group smoking cessation treatment in people with Depression and Smoking, run by US Department of Veterans Affairs 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 3 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: finished, as of the sponsor's last update on 2 Mar 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
tobacco 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?
On the ClinicalTrials.gov record for NCT00018174, which also lists 2 linked publications.
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 2 Mar 2009.