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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA011645 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to combine a smoke ending aid with behavioral treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accu Drops (AD&C) | Experimental | The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy. |
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| Placebo | Placebo Comparator | The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Therapy | Behavioral | Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter W Gariti, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 6178 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15223089 | Background | 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. |
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The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.
Participants were recruited to a university based center for the study of addictions in 2002.
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| ID | Title | Description |
|---|---|---|
| FG000 | Accu Drops (AD&C) | The experimental group (N=30) will be prescribed active Accu Drops (AD&C) |
| FG001 | Placebo (PD&C) | The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Accu Drop Plus Counseling | Active product and systematic cigarette tapering plus counseling. |
| BG001 | Placebo Accu Drop Plus Counseling | Placebo product and systematic cigarette tapering plus counseling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Accu Drops (AD&C) | The experimental group (N=30) will be prescribed active Accu Drops (AD&C) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Gariti | University of Pennsylvania | gar1iti@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo (PD&C) | The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) | 0 | 30 | 0 | 30 |
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| D001519 | Behavior |