Tobacco UsePhase 1NCT00224965
Early Tobacco Abstinence - 5
A Phase 1 study testing Behavior Therapy in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
This proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 2004
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) between ages 18-60 years; (2) able to read and write English (3) SMOKER: Smoking >10 cigarettes per day for at least 1 year, with CO > 10 ppm, and blood cotinine concentration of 150 ng/ml or greater, FTND scores > 5.
- DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, but having scores > 10 on the CES-D indicating presence of depressive symptomatology (5) NON-DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, CES-D scores <10.
- HEAVY DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking 20 or more drinks per month.
- LIGHT DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking ten drinks or less per month
Who cannot join
- Current dependence on cocaine, marijuana, opiates or alcohol
- Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
- Regular use of any psychoactive drugs including anxiolytics and antidepressants;
- Current major depression or other psychiatric conditions
- Subjects with any significant, untreated current medical conditions condition such as neurological, endocrine, cardiovascular, renal, liver, thyroid pathology or on medications for any recent medical events 6) Pregnant or lactating women -
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University, Dept. of Psychiatry
Minneapolis, Minnesota, 55415
About this study
Official title: Early Tobacco Abstinence in High Risk Smokers
This proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms.
Read the detailed description
- To compare male and female smokers, with and without current depressive symptoms, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence and,
- To compare male and female smokers, who are either heavy alcohol drinkers or light alcohol drinkers, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence.
- Conditions
- Tobacco Use
- Being tested
- Behavior Therapy
- Keywords
- nicotine dependence
- Medical subject headings
- Tobacco Use, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephanie O'Malley, Ph.D., Principal investigator, Substance Abuse Treatment Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224965
- Sponsor's protocol ID
- NIDA-13334-5
- Other IDs
- P50-13334-5
- Status last verified
- Sep 2005
- First submitted
- 22 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Tobacco Abstinence in High Risk Smokers
- ClinicalTrials.gov ID
- NCT00224965
- Acronym / sponsor ID
- NIDA-13334-5
- Conditions
- Tobacco Use
- Keywords
- nicotine dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 140 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study completion
- Oct 2004
- First posted
- 23 Sep 2005 (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 proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms.
Detailed description
- To compare male and female smokers, with and without current depressive symptoms, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence and,
- To compare male and female smokers, who are either heavy alcohol drinkers or light alcohol drinkers, in a prospective study of the intensity, content \& duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1) between ages 18-60 years; (2) able to read and write English (3) SMOKER: Smoking >10 cigarettes per day for at least 1 year, with CO > 10 ppm, and blood cotinine concentration of 150 ng/ml or greater, FTND scores > 5.
- DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, but having scores > 10 on the CES-D indicating presence of depressive symptomatology (5) NON-DEPRESSED SUBJECT: Not meeting SCID criteria for current major depression or more than one past major depressive episode, CES-D scores <10.
- HEAVY DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking 20 or more drinks per month.
- LIGHT DRINKER: Not meeting SCID criteria for current alcohol dependence; drinking ten drinks or less per month
Key exclusion criteria (5 listed)
- Current dependence on cocaine, marijuana, opiates or alcohol
- Positive urine screen for marijuana, cocaine or opiates at any appointment after the intake appointment.
- Regular use of any psychoactive drugs including anxiolytics and antidepressants;
- Current major depression or other psychiatric conditions
- Subjects with any significant, untreated current medical conditions condition such as neurological, endocrine, cardiovascular, renal, liver, thyroid pathology or on medications for any recent medical events 6) Pregnant or lactating women -
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
Related trials for Tobacco Use
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
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.
Stephanie O'Malley, Ph.D. principal investigator
Substance Abuse Treatment Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Behavior Therapy in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) 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 5 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: stopped early, as of the sponsor's last update on 12 Jan 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 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.
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 stopped early. Results are not available in the source record.
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.
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 12 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.