Opioid Related Disorders, Smoking Cessation
Conditions
Keywords
varenicline, buprenorphine
Brief summary
The primary purpose of this study was to examine the feasibility of integrating a smoking cessation intervention for cigarette smokers enrolled in an outpatient program for opioid dependence. The secondary purpose was to compare treatment effects as a function of phase in the outpatient program: 0-90 days (weekly attendance), 90 days-1 year (biweekly attendance), and more than 1 year (monthly attendance).
Detailed description
Tobacco smoking rates are substantially higher among individuals with substance use disorders (SUDs), relative to individuals in the general population (e.g., 97% vs. 19%, respectively). Yet most treatment programs for SUDs fail to address the use of tobacco among patients, and integration of smoking cessation treatment with SUD treatment may improve outcomes for both drugs. The question remains, however, whether to implement a smoking cessation component immediately or only after a patient is stabilized on their SUD pharmacotherapy. Existing research that directly addresses this factor is limited and findings are mixed. Therefore, the purpose of this study was to compare drug use outcomes among patients at three different stages of their SUD treatment: 0-90 days (weekly clinic attendance), 90 days-1 year (biweekly clinic attendance), and more than 1 year (monthly clinic attendance) of consistent abstinence from illicit drugs. Smokers currently in treatment for opioid dependence, at the WVU Comprehensive Opioid Addiction Treatment (COAT) program, were recruited to participate in this 12-week study. Our goal was to complete 20 patients from each of the three COAT treatment groups. During the 12-week intervention period, individuals continued to attend their regular COAT clinic appointments while following a standard varenicline (Chantix®) dosing regimen and responding to questions daily via text messaging (e.g., adherence to varenicline, use of tobacco, tobacco withdrawal side effects, etc.). The primary outcomes are those relevant to feasibility: 1) recruitment, randomization, and retention, 2) adherence to medication regimen, and 3) compliance with responding to text message-based questions. Secondary outcomes include a comparison of the three COAT treatment groups on 1) relapses for all substances, 2) the proportion of smokers abstinent at each assessment (confirmed with expired air carbon monoxide samples), 3) days until successful cigarette quit day, 4) substance withdrawal and medication side effect symptoms, 5) motivation to quit tobacco, and 6) cigarette quit attempts.
Interventions
DRUGvarenicline
Participants followed the schedule of dosing that is specified on the label: 0.5 mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84).
Sponsors
Pfizer
National Institute on Drug Abuse (NIDA)
West Virginia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants in all 3 study arms were given the same intervention treatment. Arms differed only by the number of days they had been enrolled in an outpatient opioid dependence program.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* enrolled in the Comprehensive Opioid Addiction Treatment (COAT) program * report smoking \>10 cigarettes per day for \>1 year * provide an expired air carbon monoxide (CO) reading of \>10 parts/million (ppm) * report interest in making a quit attempt in the next 1-6 months (Contemplation or Preparation stages via the Stage of Change; Prochaska & Diclemente, 1983) * willing to try varenicline for smoking cessation
Exclusion criteria
* current engagement in any form of tobacco cessation (e.g., pharmacotherapy) * current use of contraindicated medications (e.g., theophylline, warfarin, insulin) * Stage of Change category as Precontemplation (no plans to quit), Action (actively trying to quit), or Maintenance (have already quit) * self-reported seizures in the past year * untreated cardiovascular disease * self-report breast-feeding * pregnancy (verified by urinalysis) * not within 4 weeks of advancing to the next COAT group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment, Assignment to Treatment, and Retention Rates | up to 12 weeks | For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics. |
| Percentage of Days on Which Participants Experienced Each Reason for Attrition | up to 4 weeks | Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks. |
| Number of Study Days With Protocol Non-Adherence | up to 12 weeks | Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of no) or b) had a missing medication response (i.e. provided no response) via text message. Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message. |
| Medication Acceptability for Completers | up to 12 weeks | Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expired Air Carbon Monoxide | up to 12 weeks | Expired air carbon monoxide levels were measured for participants every 4 weeks at their in-person study visits, resulting in 4 separate measures across the 12-week period. |
| Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | up to 12 weeks | Relapse was determined by semi-quantitative urine testing (positive vs negative result). Positive results for illicit drugs were assessed separately (opioids, cocaine, THC, benzodiazepines, amphetamines, and atypical antipsychotics). |
| Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Up to 12 weeks | A quit attempt was defined as at least one study day on which 0 cigarettes smoked was reported via text message. Actual quit rates were determined by biochemically verified cigarette abstinence, which was an expired air carbon monoxide reading of \< 8 parts per million (ppm). |
| Number of Participants That Moved in Stage of Change for Quitting Smoking | up to 12 weeks | Participants indicated one of the following stages of change at each of their four in-person study visits: Precontemplation (no plans to quit smoking), Contemplation (plans to quit smoking in the next 6 months), Preparation (plans to quit smoking in the next 30 days), Action (currently engaging in quitting smoking), or Maintenance (quit smoking more than 6 months ago). Data were quantified by determining the number of participants who moved towards quitting (i.e., moved up one or more stages), the number of participants who moved away from quitting (i.e., moved down one or more stages), and and the number of participants who remained in the same stage. |
| Readiness to Quit Smoking | up to 12 weeks | The Readiness to Quit Ladder was administered to participants at each of their in-person study visits, for a total of 4 data collections. Participants were asked to indicate their readiness to quit smoking on a scale ranging from 0 (I have no interest in quitting smoking) to 10 (I have already quit smoking). |
| Number of Study Days Until First Cigarette Quit Attempt | up to 12 weeks | A quit attempt was defined as at least one day on which participants reported 0 cigarettes smoked via text message. Reports of \>0 cigarettes on subsequent days was indicative of relapse. |
| Cigarettes Smoked Per Day | up to 12 weeks | The number of cigarettes smoked per day were reported via text message by participants daily. These numbers were averaged within weeks to give 12 separate average weekly values for cigarettes per day. |
| Drug Withdrawal Ratings | up to 12 weeks | Average self-reported ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other; scores ranged from 0-10 and higher scores indicate higher levels of that withdrawal effect |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Comprehensive Outpatient Addiction Treatment (COAT) program at Chestnut Ridge Hospital on the campus of West Virginia University. Participants were recruited from the COAT clinic between 7/8/2016 and 2/2/2017.
Pre-assignment details
All participants that were enrolled (after passing the initial screening and not meeting any of the exclusion criteria) were assigned a group.
Participants by arm
| Arm | Count |
|---|---|
| Weekly Opioid Tx Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack | 32 |
| Bi-weekly Opioid Tx Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack | 28 |
| Monthly Opioid Tx Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack | 14 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 16 | 11 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 3 |
Baseline characteristics
| Characteristic | Weekly Opioid Tx | Bi-weekly Opioid Tx | Monthly Opioid Tx | Total |
|---|---|---|---|---|
| Age, Continuous | 32.38 years STANDARD_DEVIATION 6.66 | 32.68 years STANDARD_DEVIATION 6.61 | 36.71 years STANDARD_DEVIATION 10.36 | 33.67 years STANDARD_DEVIATION 7.8 |
| Cigarette Dependence Score | 6.84 units on a scale STANDARD_DEVIATION 1.95 | 6.64 units on a scale STANDARD_DEVIATION 1.91 | 7.43 units on a scale STANDARD_DEVIATION 1.99 | 6.93 units on a scale STANDARD_DEVIATION 1.96 |
| Cigarettes Smoked per Day | 23.09 cigarettes per day STANDARD_DEVIATION 9.19 | 23.15 cigarettes per day STANDARD_DEVIATION 8.34 | 27.00 cigarettes per day STANDARD_DEVIATION 9.27 | 23.31 cigarettes per day STANDARD_DEVIATION 9.49 |
| Consecutive Days in Opioid Treatment | 45.65 days STANDARD_DEVIATION 132.1 | 145.57 days STANDARD_DEVIATION 97.82 | 702.38 days STANDARD_DEVIATION 502.62 | 193.08 days STANDARD_DEVIATION 319.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 27 Participants | 14 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Expired-air Carbon Monoxide | 35.72 parts per million (ppm) STANDARD_DEVIATION 17.4 | 33.69 parts per million (ppm) STANDARD_DEVIATION 12.43 | 33.14 parts per million (ppm) STANDARD_DEVIATION 15.2 | 33.92 parts per million (ppm) STANDARD_DEVIATION 16.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 27 Participants | 14 Participants | 73 Participants |
| Sex: Female, Male Female | 16 Participants | 11 Participants | 9 Participants | 36 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 5 Participants | 38 Participants |
| Years Smoking | 12.72 years STANDARD_DEVIATION 7.48 | 11.23 years STANDARD_DEVIATION 6.38 | 14.73 years STANDARD_DEVIATION 10.78 | 12.40 years STANDARD_DEVIATION 7.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 28 | 0 / 14 |
| other Total, other adverse events | 0 / 32 | 0 / 28 | 0 / 14 |
| serious Total, serious adverse events | 0 / 32 | 0 / 28 | 0 / 14 |
Outcome results
Primary
Medication Acceptability for Completers
Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms.
Time frame: up to 12 weeks
Population: Only analyzed data for participants that completed the entire 12-week protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Medication Acceptability for Completers | Headache | 2.21 points on a scale | Standard Deviation 1.76 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Abnormal Dreams | 3.42 points on a scale | Standard Deviation 2.61 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Gas/Constipation | 3.41 points on a scale | Standard Deviation 2.65 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Nausea | 2.55 points on a scale | Standard Deviation 2.08 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Drowsy | 3.40 points on a scale | Standard Deviation 2.56 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Depressed Mood | 2.94 points on a scale | Standard Deviation 2.59 |
| Weekly Opioid Tx | Medication Acceptability for Completers | Sleep Disturbances | 3.35 points on a scale | Standard Deviation 2.89 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Gas/Constipation | 2.30 points on a scale | Standard Deviation 1.98 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Nausea | 1.46 points on a scale | Standard Deviation 0.84 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Headache | 1.61 points on a scale | Standard Deviation 1.4 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Sleep Disturbances | 2.18 points on a scale | Standard Deviation 1.67 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Abnormal Dreams | 2.94 points on a scale | Standard Deviation 2.16 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Depressed Mood | 2.15 points on a scale | Standard Deviation 1.59 |
| Bi-weekly Opioid Tx | Medication Acceptability for Completers | Drowsy | 2.05 points on a scale | Standard Deviation 1.65 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Abnormal Dreams | 0.82 points on a scale | Standard Deviation 1.03 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Headache | 1.92 points on a scale | Standard Deviation 2.66 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Drowsy | 2.36 points on a scale | Standard Deviation 2.79 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Depressed Mood | 1.10 points on a scale | Standard Deviation 0.9 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Gas/Constipation | 2.48 points on a scale | Standard Deviation 2.47 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Sleep Disturbances | 1.07 points on a scale | Standard Deviation 1.6 |
| Monthly Opioid Tx | Medication Acceptability for Completers | Nausea | 3.09 points on a scale | Standard Deviation 3.59 |
Comparison: One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.p-value: <0.05ANOVA
Primary
Number of Study Days With Protocol Non-Adherence
Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of no) or b) had a missing medication response (i.e. provided no response) via text message. Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message.
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were analyzed. Data were analyzed as a single group/arm as pre-specified in the protocol.~N=2940 study days (84 days per participant) was the unit of analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Weekly Opioid Tx | Number of Study Days With Protocol Non-Adherence | Days with missing text data | 1105 study days |
| Weekly Opioid Tx | Number of Study Days With Protocol Non-Adherence | Days of not taking medication | 40 study days |
| Weekly Opioid Tx | Number of Study Days With Protocol Non-Adherence | Days of not reporting medication use | 305 study days |
Primary
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks.
Time frame: up to 4 weeks
Population: Participants that completed the entire 12-week study were compared to those that dropped out before completing to determine potential reasons for attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Nausea | 60.3 percentage of study days | Standard Deviation 38 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Headache | 47.2 percentage of study days | Standard Deviation 38.4 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Sleep Problems | 37.9 percentage of study days | Standard Deviation 37.3 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Gas/Constipation | 45.9 percentage of study days | Standard Deviation 40 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Abnormal Dreams | 42.0 percentage of study days | Standard Deviation 33.7 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Depressed Mood | 39.6 percentage of study days | Standard Deviation 39.6 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Drowsy | 52.8 percentage of study days | Standard Deviation 36.4 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Craving | 86.5 percentage of study days | Standard Deviation 23.2 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Irritability | 72.6 percentage of study days | Standard Deviation 35.1 |
| Weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Restlessness | 58.7 percentage of study days | Standard Deviation 40.7 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Craving | 78.1 percentage of study days | Standard Deviation 28.9 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Nausea | 43.4 percentage of study days | Standard Deviation 35.4 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Depressed Mood | 49.0 percentage of study days | Standard Deviation 38 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Headache | 39.8 percentage of study days | Standard Deviation 32.1 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Restlessness | 56.7 percentage of study days | Standard Deviation 37.8 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Sleep Problems | 46.6 percentage of study days | Standard Deviation 40 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Drowsy | 50.3 percentage of study days | Standard Deviation 36.4 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Gas/Constipation | 48.9 percentage of study days | Standard Deviation 37.3 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Irritability | 70.4 percentage of study days | Standard Deviation 29.8 |
| Bi-weekly Opioid Tx | Percentage of Days on Which Participants Experienced Each Reason for Attrition | Abnormal Dreams | 53.7 percentage of study days | Standard Deviation 38.6 |
Comparison: A separate t-test for each row was used to compare dropouts and completers.p-value: <0.05t-test, 2 sided
Primary
Recruitment, Assignment to Treatment, and Retention Rates
For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.
Time frame: up to 12 weeks
Population: All participants that completed informed consent were included to calculate rates of assignment to treatment (N=88). This is different from the number of participants enrolled (N=74) because n=14 participants provided informed consent but were then found to be ineligible for the study based on initial questionnaires.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Recruited and Consented | 40 Participants |
| Weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 8 Weeks | 12 Participants |
| Weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 4 Weeks | 20 Participants |
| Weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 12 Weeks | 12 Participants |
| Weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Assigned to Treatment | 32 Participants |
| Bi-weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 12 Weeks | 15 Participants |
| Bi-weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Recruited and Consented | 33 Participants |
| Bi-weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Assigned to Treatment | 28 Participants |
| Bi-weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 4 Weeks | 19 Participants |
| Bi-weekly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 8 Weeks | 15 Participants |
| Monthly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Assigned to Treatment | 14 Participants |
| Monthly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 12 Weeks | 8 Participants |
| Monthly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 8 Weeks | 9 Participants |
| Monthly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Recruited and Consented | 15 Participants |
| Monthly Opioid Tx | Recruitment, Assignment to Treatment, and Retention Rates | Completed 4 Weeks | 13 Participants |
Secondary
Cigarettes Smoked Per Day
The number of cigarettes smoked per day were reported via text message by participants daily. These numbers were averaged within weeks to give 12 separate average weekly values for cigarettes per day.
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 1 | 18.21 cigarettes per day | Standard Error 2.8 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 2 | 14.28 cigarettes per day | Standard Error 2.3 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 3 | 11.90 cigarettes per day | Standard Error 2.17 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 4 | 9.34 cigarettes per day | Standard Error 1.95 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 5 | 9.35 cigarettes per day | Standard Error 2.17 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 6 | 9.21 cigarettes per day | Standard Error 1.98 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 7 | 9.40 cigarettes per day | Standard Error 2.13 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 8 | 8.87 cigarettes per day | Standard Error 1.99 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 9 | 7.98 cigarettes per day | Standard Error 1.91 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 10 | 8.34 cigarettes per day | Standard Error 2.04 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 11 | 7.83 cigarettes per day | Standard Error 2.03 |
| Weekly Opioid Tx | Cigarettes Smoked Per Day | Week 12 | 7.35 cigarettes per day | Standard Error 2.19 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 12 | 10.39 cigarettes per day | Standard Error 1.83 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 1 | 15.53 cigarettes per day | Standard Error 1.74 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 7 | 9.45 cigarettes per day | Standard Error 1.88 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 9 | 9.58 cigarettes per day | Standard Error 1.85 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 2 | 12.02 cigarettes per day | Standard Error 1.4 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 6 | 9.85 cigarettes per day | Standard Error 1.66 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 11 | 10.90 cigarettes per day | Standard Error 2.03 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 3 | 10.21 cigarettes per day | Standard Error 1.66 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 8 | 9.87 cigarettes per day | Standard Error 1.8 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 5 | 9.52 cigarettes per day | Standard Error 1.63 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 4 | 9.58 cigarettes per day | Standard Error 1.39 |
| Bi-weekly Opioid Tx | Cigarettes Smoked Per Day | Week 10 | 9.47 cigarettes per day | Standard Error 1.79 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 4 | 8.11 cigarettes per day | Standard Error 2.37 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 5 | 7.91 cigarettes per day | Standard Error 2.29 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 10 | 6.37 cigarettes per day | Standard Error 2.21 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 6 | 6.68 cigarettes per day | Standard Error 2.01 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 7 | 7.00 cigarettes per day | Standard Error 2.3 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 8 | 7.13 cigarettes per day | Standard Error 2.22 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 11 | 6.83 cigarettes per day | Standard Error 2.17 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 1 | 16.00 cigarettes per day | Standard Error 2 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 2 | 11.18 cigarettes per day | Standard Error 2.07 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 9 | 6.55 cigarettes per day | Standard Error 2.1 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 3 | 8.04 cigarettes per day | Standard Error 2.1 |
| Monthly Opioid Tx | Cigarettes Smoked Per Day | Week 12 | 5.23 cigarettes per day | Standard Error 1.66 |
Comparison: Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.p-value: <0.05ANOVA
Secondary
Drug Withdrawal Ratings
Average self-reported ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other; scores ranged from 0-10 and higher scores indicate higher levels of that withdrawal effect
Time frame: up to 12 weeks
Population: Only analyzed data for participants that completed the entire 12-week protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Drug Withdrawal Ratings | Craving | 5.03 units on a scale | Standard Deviation 1.85 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Irritability | 4.37 units on a scale | Standard Deviation 1.87 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Restless | 3.67 units on a scale | Standard Deviation 2.36 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Alert | 6.23 units on a scale | Standard Deviation 1.76 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Bored | 2.98 units on a scale | Standard Deviation 1.64 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Calm/Relaxed | 5.12 units on a scale | Standard Deviation 2.4 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Able to Focus | 6.11 units on a scale | Standard Deviation 2.2 |
| Weekly Opioid Tx | Drug Withdrawal Ratings | Nervous | 2.93 units on a scale | Standard Deviation 2.81 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Restless | 1.97 units on a scale | Standard Deviation 1.49 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Able to Focus | 5.48 units on a scale | Standard Deviation 2.12 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Alert | 5.26 units on a scale | Standard Deviation 2.17 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Bored | 1.72 units on a scale | Standard Deviation 1.25 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Calm/Relaxed | 4.74 units on a scale | Standard Deviation 2.29 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Craving | 4.55 units on a scale | Standard Deviation 1.73 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Irritability | 3.09 units on a scale | Standard Deviation 1.75 |
| Bi-weekly Opioid Tx | Drug Withdrawal Ratings | Nervous | 1.96 units on a scale | Standard Deviation 1.65 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Restless | 1.87 units on a scale | Standard Deviation 2.05 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Irritability | 2.67 units on a scale | Standard Deviation 2.27 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Craving | 4.16 units on a scale | Standard Deviation 3.19 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Alert | 7.98 units on a scale | Standard Deviation 1.08 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Able to Focus | 8.08 units on a scale | Standard Deviation 0.79 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Calm/Relaxed | 6.75 units on a scale | Standard Deviation 2.18 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Bored | 1.58 units on a scale | Standard Deviation 1.74 |
| Monthly Opioid Tx | Drug Withdrawal Ratings | Nervous | 1.62 units on a scale | Standard Deviation 2.41 |
Comparison: One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.p-value: <0.05ANOVA
Secondary
Expired Air Carbon Monoxide
Expired air carbon monoxide levels were measured for participants every 4 weeks at their in-person study visits, resulting in 4 separate measures across the 12-week period.
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Expired Air Carbon Monoxide | Baseline | 46.00 parts per million (ppm) | Standard Deviation 20.75 |
| Weekly Opioid Tx | Expired Air Carbon Monoxide | Week 4 | 34.18 parts per million (ppm) | Standard Deviation 14.86 |
| Weekly Opioid Tx | Expired Air Carbon Monoxide | Week 8 | 37.45 parts per million (ppm) | Standard Deviation 19.93 |
| Weekly Opioid Tx | Expired Air Carbon Monoxide | Week 12 | 34.00 parts per million (ppm) | Standard Deviation 18.42 |
| Bi-weekly Opioid Tx | Expired Air Carbon Monoxide | Week 12 | 25.27 parts per million (ppm) | Standard Deviation 9.55 |
| Bi-weekly Opioid Tx | Expired Air Carbon Monoxide | Baseline | 34.27 parts per million (ppm) | Standard Deviation 11.6 |
| Bi-weekly Opioid Tx | Expired Air Carbon Monoxide | Week 8 | 28.60 parts per million (ppm) | Standard Deviation 12.77 |
| Bi-weekly Opioid Tx | Expired Air Carbon Monoxide | Week 4 | 30.00 parts per million (ppm) | Standard Deviation 11.58 |
| Monthly Opioid Tx | Expired Air Carbon Monoxide | Week 12 | 24.63 parts per million (ppm) | Standard Deviation 15.03 |
| Monthly Opioid Tx | Expired Air Carbon Monoxide | Week 4 | 26.13 parts per million (ppm) | Standard Deviation 18.34 |
| Monthly Opioid Tx | Expired Air Carbon Monoxide | Week 8 | 25.00 parts per million (ppm) | Standard Deviation 17.67 |
| Monthly Opioid Tx | Expired Air Carbon Monoxide | Baseline | 34.25 parts per million (ppm) | Standard Deviation 13.65 |
Comparison: Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.p-value: <0.05ANOVA
Secondary
Number of Participants That Moved in Stage of Change for Quitting Smoking
Participants indicated one of the following stages of change at each of their four in-person study visits: Precontemplation (no plans to quit smoking), Contemplation (plans to quit smoking in the next 6 months), Preparation (plans to quit smoking in the next 30 days), Action (currently engaging in quitting smoking), or Maintenance (quit smoking more than 6 months ago). Data were quantified by determining the number of participants who moved towards quitting (i.e., moved up one or more stages), the number of participants who moved away from quitting (i.e., moved down one or more stages), and and the number of participants who remained in the same stage.
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were included in analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved toward quitting | 7 Participants |
| Weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved away from quitting | 4 Participants |
| Weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Stayed the same | 1 Participants |
| Bi-weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved toward quitting | 6 Participants |
| Bi-weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved away from quitting | 1 Participants |
| Bi-weekly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Stayed the same | 8 Participants |
| Monthly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved away from quitting | 0 Participants |
| Monthly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Stayed the same | 4 Participants |
| Monthly Opioid Tx | Number of Participants That Moved in Stage of Change for Quitting Smoking | Moved toward quitting | 4 Participants |
Secondary
Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit
A quit attempt was defined as at least one study day on which 0 cigarettes smoked was reported via text message. Actual quit rates were determined by biochemically verified cigarette abstinence, which was an expired air carbon monoxide reading of \< 8 parts per million (ppm).
Time frame: Up to 12 weeks
Population: Only analyzed data for participants that completed the entire 12-week protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weekly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Attempt Rates | 2 Participants |
| Weekly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Rates | 0 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Attempt Rates | 2 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Rates | 1 Participants |
| Monthly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Attempt Rates | 2 Participants |
| Monthly Opioid Tx | Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit | Quit Rates | 2 Participants |
Secondary
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Relapse was determined by semi-quantitative urine testing (positive vs negative result). Positive results for illicit drugs were assessed separately (opioids, cocaine, THC, benzodiazepines, amphetamines, and atypical antipsychotics).
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Amphetamine | 1 Participants |
| Weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Cocaine | 2 Participants |
| Weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | THC | 5 Participants |
| Weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Benzodiazapines | 4 Participants |
| Weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Atypical antipsychotics | 1 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Cocaine | 1 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | THC | 2 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Benzodiazapines | 1 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Amphetamine | 0 Participants |
| Bi-weekly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Atypical antipsychotics | 0 Participants |
| Monthly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Atypical antipsychotics | 0 Participants |
| Monthly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Amphetamine | 0 Participants |
| Monthly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | THC | 0 Participants |
| Monthly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Cocaine | 0 Participants |
| Monthly Opioid Tx | Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc) | Benzodiazapines | 1 Participants |
Secondary
Number of Study Days Until First Cigarette Quit Attempt
A quit attempt was defined as at least one day on which participants reported 0 cigarettes smoked via text message. Reports of \>0 cigarettes on subsequent days was indicative of relapse.
Time frame: up to 12 weeks
Population: For this outcome measure, we include only participants that reported at least one study day on which they smoked 0 cigarettes (i.e., made a quit attempt).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly Opioid Tx | Number of Study Days Until First Cigarette Quit Attempt | 35.5 number of study days | Standard Deviation 24.7 |
| Bi-weekly Opioid Tx | Number of Study Days Until First Cigarette Quit Attempt | 11.5 number of study days | Standard Deviation 12 |
| Monthly Opioid Tx | Number of Study Days Until First Cigarette Quit Attempt | 12.5 number of study days | Standard Deviation 3.5 |
Secondary
Readiness to Quit Smoking
The Readiness to Quit Ladder was administered to participants at each of their in-person study visits, for a total of 4 data collections. Participants were asked to indicate their readiness to quit smoking on a scale ranging from 0 (I have no interest in quitting smoking) to 10 (I have already quit smoking).
Time frame: up to 12 weeks
Population: Only data for participants that completed the entire 12-week protocol were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weekly Opioid Tx | Readiness to Quit Smoking | Baseline | 6.17 units on a scale | Standard Deviation 0.83 |
| Weekly Opioid Tx | Readiness to Quit Smoking | Week 4 | 7.50 units on a scale | Standard Deviation 0.8 |
| Weekly Opioid Tx | Readiness to Quit Smoking | Week 8 | 7.50 units on a scale | Standard Deviation 0.52 |
| Weekly Opioid Tx | Readiness to Quit Smoking | Week 12 | 8.33 units on a scale | Standard Deviation 1.07 |
| Bi-weekly Opioid Tx | Readiness to Quit Smoking | Week 12 | 7.53 units on a scale | Standard Deviation 0.83 |
| Bi-weekly Opioid Tx | Readiness to Quit Smoking | Baseline | 5.87 units on a scale | Standard Deviation 1.13 |
| Bi-weekly Opioid Tx | Readiness to Quit Smoking | Week 8 | 7.47 units on a scale | Standard Deviation 0.74 |
| Bi-weekly Opioid Tx | Readiness to Quit Smoking | Week 4 | 7.20 units on a scale | Standard Deviation 0.86 |
| Monthly Opioid Tx | Readiness to Quit Smoking | Week 12 | 8.13 units on a scale | Standard Deviation 0.64 |
| Monthly Opioid Tx | Readiness to Quit Smoking | Week 4 | 7.88 units on a scale | Standard Deviation 1.25 |
| Monthly Opioid Tx | Readiness to Quit Smoking | Week 8 | 8.38 units on a scale | Standard Deviation 0.74 |
| Monthly Opioid Tx | Readiness to Quit Smoking | Baseline | 5.63 units on a scale | Standard Deviation 1.69 |
Comparison: Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.p-value: <0.05ANOVA