Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of ExpiredCO Level From Baseline | End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction. | Weekly for 12 weeks |
| Level of Nicotine Dependence by Treatment Assignment | Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence. | Weekly for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) - Total Score | The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elaine Weiner, M.D. | Maryland Psychiatric Research Center | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. |
Not provided
Not provided
After the enrollment of 16 participants, a total of 7 participants were withdrawn from the study prior to assignment to a treatment group (n=9). Two subjects met exclusion criteria before any study procedures were started, and 5 subjects were withdrawn during either the "evaluation" or "pre-med" phases of the study.
Stable outpatients who received their regular treatment at the Outpatient Research Program of the MPRC were invited to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
| FG001 | Placebo | placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant was withdrawn by the P.I. after assignment to the placebo group, but prior to receiving treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change of ExpiredCO Level From Baseline | End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction. | Some ExpiredCO data is missing due to rater error or participant absence from that study visit. | Posted | Mean | Standard Deviation | ppm | Weekly for 12 weeks |
|
Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline | Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | One subject was taken to the ER after exhibiting anxiety symptoms. This participant had a long history of going to the emergency room when he feels anxious due to worsening of anxiety, therefore, it is unlikely that the SAE was study drug related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
Larger studies are needed to confirm these encouraging results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Weiner, M.D. | Maryland Psychiatric Research Center | 410-402-7694 | eweiner@mprc.umaryland.edu |
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019967 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D004341 | Drug Evaluation |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| placebo | Drug | At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
|
|
| Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
| Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating. | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
| Side Effects | Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug. | Weekly for 12 weeks |
| BG001 | Placebo | placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|
| Primary | Level of Nicotine Dependence by Treatment Assignment | Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence. | Some FTND data is missing due to rater error or participant absence from that study visit. | Posted | Mean | Standard Deviation | units on a scale | Weekly for 12 weeks |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) - Total Score | The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. | Some BPRS total score data is missing due to rater error or participant absence from that study visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. | Some BPRS total score data is missing due to rater error or participant absence from that study visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating. | Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. |
|
|
|
| Secondary | Side Effects | Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug. | Posted | Count of Participants | Participants | Weekly for 12 weeks |
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | Placebo | Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. | 1 | 4 | 1 | 4 |
|
| Headache | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated liver enzymes | Hepatobiliary disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D011810 | Quinoxalines |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D002241 | Carbohydrates |
| Treatment Week 1 |
|
|
| Treatment Week 2 |
|
|
| Treatment Week 3 |
|
|
| Treatment Week 4 |
|
|
| Treatment Week 5 |
|
|
| Treatment Week 6 |
|
|
| Treatment Week 7 |
|
|
| Treatment Week 8 |
|
|
| Treatment Week 9 |
|
|
| Treatment Week 10 |
|
|
| Treatment Week 11 |
|
|
| Treatment Week 12 |
|
|
| Treatment Week 1 |
|
|
| Treatment Week 2 |
|
|
| Treatment Week 4 |
|
|
| Treatment Week 8 |
|
|
| Treatment Week 12 |
|
|
| Treatment Week 1 |
|
|
| Treatment Week 2 |
|
|
| Treatment Week 4 |
|
|
| Treatment Week 8 |
|
|
| Treatment Week 12 |
|
|
| Treatment Week 1 |
|
|
| Treatment Week 2 |
|
|
| Treatment Week 4 |
|
|
| Treatment Week 8 |
|
|
| Treatment Week 12 |
|
|
| Bruising |
|
| Constipation |
|
| Diarrhea |
|
| Dizziness |
|
| Dry mouth |
|
| Enuresis |
|
| Fever |
|
| Headache |
|
| Insomnia |
|
| Malaise |
|
| Mucosal ulceration |
|
| Nausea |
|
| Rash |
|
| Restlessness |
|
| Hypersalivation |
|
| Sedation |
|
| Stiffness |
|
| Sore throat |
|
| Tremor |
|
| Uticaria |
|
| Vomiting |
|
| Weight loss |
|
| Tinnitus |
|