An interventional study of Behavioral Therapy in Tobacco Use Disorder, sponsored by Peter Gariti. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by Peter Gariti · Not applicable, Interventional, and Treatment
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.
988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →This is the only study on the registry with Peter Gariti as lead sponsor.
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Exclusion Criteria:
The experimental group (N=30) will be prescribed active Accu Drops (AD\&C) plus behavioral therapy.
Behavioral: Behavioral Therapy
The control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) plus behavioral therapy.
Behavioral: Behavioral Therapy
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
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.
Time frame: 1 year
Participants were recruited to a university based center for the study of addictions in 2002.
| Milestone | Accu Drops (AD&C) | Placebo (PD&C) |
|---|---|---|
| Started | 30 | 30 |
| Completed | 17 | 16 |
| Not completed | 13 | 14 |
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.
| participants | Accu Drop Plus Counseling | Placebo Accu Drop Plus Counseling |
|---|---|---|
| Abstinence Rate | 3 | 4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Accu Drops (AD&C) | — | 0/30 (0%) | 0/30 (0%) |
| Placebo (PD&C) | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Accu Drop Plus Counseling | Placebo Accu Drop Plus Counseling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Accu Drop Plus Counseling | Placebo Accu Drop Plus Counseling | Total |
|---|---|---|---|
| Mean | 47.07 ± 11.4 | 43.50 ± 12 | 45.29 ± 11.7 |
| Sex: Female, Male(Participants) | Accu Drop Plus Counseling | Placebo Accu Drop Plus Counseling | Total |
|---|---|---|---|
| Female | 17 | 20 | 37 |
| Male | 13 | 10 | 23 |
| Region of Enrollment(participants) | Accu Drop Plus Counseling | Placebo Accu Drop Plus Counseling | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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