Tobacco Use DisorderNCT00006151
Combining a Smoke Ending Aid With Behavioral Treatment - 1
A study testing Behavioral Therapy in people with Tobacco Use Disorder, run by Peter Gariti at 1 site in United States.
Trial summary
The purpose of this study is to combine a smoke ending aid with behavioral treatment. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Feb 2002
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older, and no greater than 65 years of age
- Medically stable
- Smoke at least 15 filtered cigarettes daily
- Motivated to quit smoking
Who cannot join
- Medically unstable
- Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104 6178
About this study
Official title: Combining a Smoke Ending Aid With Behavioral Treatment
The purpose of this study is to combine a smoke ending aid with behavioral treatment.
Read the detailed description
The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.
- Conditions
- Tobacco Use Disorder
- Being tested
- Behavioral Therapy
- Keywords
- nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TherapyBehavioural
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
| Study group | Role | What they receive |
|---|---|---|
| Accu Drops (AD&C) | Experimental | The experimental group (N=30) will be prescribed active Accu Drops (AD\&C) plus behavioral therapy. Receives: Behavioral: Behavioral Therapy |
| Placebo | Placebo comparator | The control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) plus behavioral therapy. Receives: Behavioral: Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Rate
The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startMay 1999
- Primary completionFeb 2002
- Study completionFeb 2002
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Gariti
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Peter Gariti, University of Pennsylvania
- Investigators
- Peter W Gariti, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006151
- Sponsor's protocol ID
- NIDA-11645-1
- Other IDs
- R01DA011645
- Status last verified
- Dec 2015
- First submitted
- 8 Aug 2000
- Last updated
- 3 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.
PubMed 15223089
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining a Smoke Ending Aid With Behavioral Treatment
- ClinicalTrials.gov ID
- NCT00006151
- Acronym / sponsor ID
- NIDA-11645-1
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peter GaritiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 1999
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 9 Aug 2000 (estimated)
- Results
- Posted 6 Jan 2014
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 combine a smoke ending aid with behavioral treatment.
Detailed description
The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accu Drops (AD&C) | Experimental | Behavioral: Behavioral TherapyThe experimental group (N=30) will be prescribed active Accu Drops (AD\&C) plus behavioral therapy. |
| Placebo | Placebo comparator | Behavioral: Behavioral TherapyThe control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) plus behavioral therapy. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years of age or older, and no greater than 65 years of age
- Medically stable
- Smoke at least 15 filtered cigarettes daily
- Motivated to quit smoking
Key exclusion criteria (3 listed)
- Medically unstable
- Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
- 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 |
|---|---|---|
| Behavioral TherapyWeekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering. | Behavioural | Accu Drops (AD&C), Placebo |
Primary outcome
Abstinence Rate
Time frame: 1 year
The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15223089Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.
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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.
Peter W Gariti, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy in people with Tobacco Use Disorder, run by Peter Gariti 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 3 Dec 2015. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2014). 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?
Abstinence Rate (time frame: 1 year). 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 NCT00006151, which also lists 1 linked publication.
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 3 Dec 2015.