Tobacco Use DisorderNCT00136838
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2
A study testing Neutral or active cigarette cues in people with Tobacco Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Neutral or active cigarette cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Jun 2006
- Phase
- Interventional
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy, on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Who cannot join
- Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the 3 months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
Show all 10Show fewer
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence
Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development.
The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.
Read the detailed description
Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. In addition, the objective of this study is to develop a laboratory model of relapse induced by cigarette exposure that would reproduce the psychological and physiological processes that are involved when abstinent individuals progress from initial cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be used to study the mechanisms of relapse and to screen medications that might be effective in preventing relapse in treatment seekers.
This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke, following the exposure to tobacco-related or control cues. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.
- Conditions
- Tobacco Use Disorder
- Being tested
- Neutral or active cigarette cues
- Keywords
- tobacco use
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral or active cigarette cuesBehavioural
Packets of cigarettes or cigarette smoke.
| Study group | Role | What they receive |
|---|---|---|
| Neutral Cue first, then Active Cue | Experimental | Each participant receives two consecutive interventions.
1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. Receives: Behavioral: Neutral or active cigarette cues |
| Active Cue first, then Neutral Cue | Experimental | Each participant receives two consecutive interventions.
1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue Receives: Behavioral: Neutral or active cigarette cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Choice After 3 Day Abstinence
Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices
Measured: During Day 4 experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startOct 2001
- Primary completionJun 2006
- Study completionJun 2006
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 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Bisaga, New York State Psychiatric Institute
- Investigators
- Adam Bisaga, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136838
- Sponsor's protocol ID
- #4725(2)
- Other IDs
- R01DA017572, R01DA017572-02, DPMC
- Status last verified
- May 2018
- First submitted
- 25 Aug 2005
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence
- ClinicalTrials.gov ID
- NCT00136838
- Acronym / sponsor ID
- #4725(2)
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Posted 11 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development.
The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.
Detailed description
Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. In addition, the objective of this study is to develop a laboratory model of relapse induced by cigarette exposure that would reproduce the psychological and physiological processes that are involved when abstinent individuals progress from initial cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be used to study the mechanisms of relapse and to screen medications that might be effective in preventing relapse in treatment seekers.
This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke, following the exposure to tobacco-related or control cues. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Cue first, then Active Cue | Experimental | Behavioral: Neutral or active cigarette cuesEach participant receives two consecutive interventions. 1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue 2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. |
| Active Cue first, then Neutral Cue | Experimental | Behavioral: Neutral or active cigarette cuesEach participant receives two consecutive interventions. 1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. 2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy, on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Key exclusion criteria (10 listed)
- Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the 3 months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
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 |
|---|---|---|
| Neutral or active cigarette cuesPackets of cigarettes or cigarette smoke. | Behavioural | Active Cue first, then Neutral Cue, Neutral Cue first, then Active Cue |
Primary outcome
Cigarette Choice After 3 Day Abstinence
Time frame: During Day 4 experimental session
Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam Bisaga, M.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral or active cigarette cues in people with Tobacco Use Disorder, run by New York State Psychiatric Institute 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 5 inclusion and 10 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 18 Jun 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2016). 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?
Cigarette Choice After 3 Day Abstinence (time frame: During Day 4 experimental session). 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 18 Jun 2018.