Nicotine DependenceNCT00816231
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
A study testing Tobacco and Alcoholic Beverage in people with Nicotine Dependence, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Tobacco and Alcoholic Beverage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2006to 20 Jun 2019
- Phase
- Interventional
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking persons who exhibit a range of alcohol consumption and smoking patterns.
- Signed written consent form.
Who cannot join
- Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.
Read the detailed description
The present project will improve and expand upon previously published work in several ways. First, Study 1 will assess reactivity to alcohol and smoking cues in the same session. Second, both studies will include within-subjects design factors to manipulate alcohol and nicotine intake, as well as cue types. Third, craving indices will represent three important response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991). Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal information concerning influences on alcohol and smoking cue reactivity across various subject populations. The proposed studies are not only important from a theory development perspective, but they will provide an excellent foundation for future laboratory-based and clinical research.
- Conditions
- Nicotine Dependence
- Being tested
- Tobacco, Alcoholic Beverage, Placebo
- Keywords
- Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobaccoBehavioural
Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session.
Alcoholic BeverageOther
Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session.
PlaceboOther
Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol and Nicotine Group | Experimental | Alcohol and Nicotine Drug/Cue Interactions Receives: Behavioral: Tobacco; Other: Alcoholic Beverage |
| Alcohol Only Group | Active comparator | Alcohol Only Drug/Cue Interactions Receives: Other: Alcoholic Beverage; Other: Placebo |
| Nicotine Only Group | Active comparator | Nicotine Only Drug/Cue Interactions Receives: Behavioral: Tobacco; Other: Placebo |
| Placebo and Placebo Group | Placebo comparator | Placebo Only Drug/Cue Interactions Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysiological Reactivity Assessment
To assess cravings and psychophysiological reactivity elicited by alcohol, smoking, and neutral cues following acute intake of alcohol and nicotine among individuals across a broad range of alcohol and cigarette use patterns (Study 1).
Measured: approximately 5 weeks per participant
Secondary outcomes (1)
Alcohol Self-administration Assessment
To assess alcohol self-administration upon exposure to alcohol or smoking-related cues following acute intake of alcohol, nicotine, or both drugs among individuals across a broad range of alcohol and cigarette use patterns (Study 2).
Measured: approximately 5 weeks per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study start8 May 2006
- Primary completionMar 2014
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Drobes, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816231
- Sponsor's protocol ID
- MCC-14671
- Status last verified
- Sep 2019
- First submitted
- 31 Dec 2008
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
- ClinicalTrials.gov ID
- NCT00816231
- Acronym / sponsor ID
- MCC-14671
- Conditions
- Nicotine Dependence
- Keywords
- Prevention Intervention, Alcohol, Tobacco, Nicotine, Craving, Cue Reactivity, Cross Cue Reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 May 2006 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 1 Jan 2009 (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.
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.
Detailed description
The present project will improve and expand upon previously published work in several ways. First, Study 1 will assess reactivity to alcohol and smoking cues in the same session. Second, both studies will include within-subjects design factors to manipulate alcohol and nicotine intake, as well as cue types. Third, craving indices will represent three important response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991). Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal information concerning influences on alcohol and smoking cue reactivity across various subject populations. The proposed studies are not only important from a theory development perspective, but they will provide an excellent foundation for future laboratory-based and clinical research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol and Nicotine Group | Experimental | Behavioral: Tobacco, Other: Alcoholic BeverageAlcohol and Nicotine Drug/Cue Interactions |
| Alcohol Only Group | Active comparator | Other: Alcoholic Beverage, Other: PlaceboAlcohol Only Drug/Cue Interactions |
| Nicotine Only Group | Active comparator | Behavioral: Tobacco, Other: PlaceboNicotine Only Drug/Cue Interactions |
| Placebo and Placebo Group | Placebo comparator | Other: PlaceboPlacebo Only Drug/Cue Interactions |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English speaking persons who exhibit a range of alcohol consumption and smoking patterns.
- Signed written consent form.
Key exclusion criteria (1 listed)
- Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.
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 |
|---|---|---|
| TobaccoFive research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session. | Behavioural | Alcohol and Nicotine Group, Nicotine Only Group |
| Alcoholic BeverageFive research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session. | Other | Alcohol Only Group, Alcohol and Nicotine Group |
| PlaceboFive research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session. | Other | Alcohol Only Group, Nicotine Only Group, Placebo and Placebo Group |
Primary outcome
Psychophysiological Reactivity Assessment
Time frame: approximately 5 weeks per participant
To assess cravings and psychophysiological reactivity elicited by alcohol, smoking, and neutral cues following acute intake of alcohol and nicotine among individuals across a broad range of alcohol and cigarette use patterns (Study 1).
1 secondary outcome
Alcohol Self-administration Assessment
Time frame: approximately 5 weeks per participant.
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 6 Sep 2019.
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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 Drobes, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research 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 Tobacco and Alcoholic Beverage in people with Nicotine Dependence, run by H. Lee Moffitt Cancer Center and Research 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 2 inclusion and 1 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 6 Sep 2019. 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.
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?
Psychophysiological Reactivity Assessment (time frame: approximately 5 weeks per participant). 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 6 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.