Trial · NCT01876810
Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction
NCT01876810, Phase 2, Completed, Centre for Addiction and Mental Health; results first posted 2017-04-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction. Trials, record NCT01876810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Initial Screening of Gemfibrozil as a Novel Treatment for Tobacco Addiction
- NCT number
- NCT01876810
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Centre for Addiction and Mental Health
- Conditions
- Nicotine Dependence
- Interventions
- Gemfibrozil, Placebo
- First posted
- 2013-06-13
- Last updated
- 2017-04-20
- Results first posted
- 2017-04-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks | 1 week in each phase | the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide \< 5 ppm |
| Secondary | The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment | during the lab forced choice paradigm after 1 week of treatment | Percentage of choice of Nicotinized cigarettes was calculated for each participant during the lab session which took place after 1 week of treatment. Each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were asked to complete some questionnaires at baseline. Then, they were asked to relax for 30 min listening to music or reading. Four exposure trials followed that were separated by 30 min of relaxation. In each exposure trial, participants took four puffs of a Nicotinized (A) or Denicotinized (less than 0.05 mg nicotine.) (B) cigarette in the order of ABAB or BABA. Cigarettes were color-coded. Participants then began four choice trials separated by 30 min of relaxation. In each trial, participants chose any combination of 4 puffs from the two cigarettes. |
| Other | Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment | during the lab Cue- reactivity paradigm after 1 week of treatment | In this study, each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were then seated in a comfortable chair and completed the baseline Visual Analogue Scale for craving 0-100 mm (The higher the number the more is the craving). The smoking cue was a pack of cigarettes and a lighter. Participants were instructed to light the cigarette without puffing and hold it for 30 sec while the physiological recordings were measured. Then the participant was asked to extinguish the cigarette. The neutral cue was an unsharpened pencil, a notepad, and a sharpener. Participants were instructed to sharpen the pencil and hold it as if writing for 30 sec. Participants completed the Visual Analogue Scale for craving during the cue, and 15 and 30 min after cue presentation. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks | 1 week in each phase | days | MEAN | |
| SECONDARY | The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment | during the lab forced choice paradigm after 1 week of treatment | percentage of choice of nicotinized ciga | MEAN | |
| OTHER_PRE_SPECIFIED | Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment | during the lab Cue- reactivity paradigm after 1 week of treatment | participants self-reportd Visual analogue scale (0-100 mm) for craving at the time of presenting the smoking cue. The higher the number on the scale, the more is the craving | units on a scale: from 0-100 mm | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks | Gemfibrozil | 0.2 | Standard Error 0.1 | days | |
| Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks | Placebo | 0 | Standard Error 0 | days | |
| The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment | Gemfibrozil | 0.775 | Standard Error 0.034 | percentage of choice of nicotinized ciga | |
| The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment | Placebo Group | 0.77 | Standard Error 0.05 | percentage of choice of nicotinized ciga | |
| Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment | Gemfibrozil | 51 | Standard Error 32.7 | units on a scale: from 0-100 mm | |
| Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment | Placebo Group | 44 | Standard Error 27.4 | units on a scale: from 0-100 mm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemfibrozil/Placebo | 14 | |
| Overall Study | STARTED | Placebo/Gemfibrozil | 14 | |
| Overall Study | COMPLETED | Gemfibrozil/Placebo | 14 | |
| Overall Study | COMPLETED | Placebo/Gemfibrozil | 13 | |
| Overall Study | NOT COMPLETED | Gemfibrozil/Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo/Gemfibrozil | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Gemfibrozil/Placebo | 3 | 14 | 3 |
| other | Headache | Nervous system disorders | Placebo/Gemfibrozil | 0 | 13 | 0 |
| other | Change in appetite | Gastrointestinal disorders | Gemfibrozil/Placebo | 2 | 14 | 2 |
| other | Change in appetite | Gastrointestinal disorders | Placebo/Gemfibrozil | 4 | 13 | 4 |
| other | stomach upset | Gastrointestinal disorders | Gemfibrozil/Placebo | 3 | 14 | 3 |
| other | stomach upset | Gastrointestinal disorders | Placebo/Gemfibrozil | 2 | 13 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemfibrozil/Placebo | 0 | 14 |
| Total, all-cause mortality | Placebo/Gemfibrozil | 0 | 13 |
| Total, other adverse events | Gemfibrozil/Placebo | 8 | 14 |
| Total, other adverse events | Placebo/Gemfibrozil | 6 | 13 |
| Total, serious adverse events | Gemfibrozil/Placebo | 0 | 14 |
| Total, serious adverse events | Placebo/Gemfibrozil | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gemfibrozil/Placebo vs Placebo/Gemfibrozil: deaths from any cause | Trial comparisons |
| Gemfibrozil/Placebo vs Placebo/Gemfibrozil: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01876810
GET https://conductscience.org/api/trials/v1/NCT01876810/registered