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| ID | Type | Description | Link |
|---|---|---|---|
| NOT-DA-16-013 | Other Identifier | National Institute on Drug Abuse |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Opioid Tx | Experimental | Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, they received 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 |
|
| Biweekly Opioid Tx | Experimental | Participants in this group attended an outpatient opioid clinic once bi-weekly. 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 |
|
| Monthly Opioid Tx | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment, Assignment to Treatment, and Retention Rates | For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics. | up to 12 weeks |
| 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. | up to 4 weeks |
| 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. | up to 12 weeks |
| 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. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa D Blank, PhD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Chestnut Ridge Center | Morgantown | West Virginia | 26505 | United States |
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All participants that were enrolled (after passing the initial screening and not meeting any of the exclusion criteria) were assigned a group.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population is the same as the assignment in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Recruitment, Assignment to Treatment, and Retention Rates | For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics. | 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. | Posted | Count of Participants | Participants | up to 12 weeks |
|
Adverse event data were collected during the entire course of participant enrollment in the study (approximately 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 | 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 |
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Due to the study's pilot nature, the sample size is relatively small and statistical power is relatively low. High rates of participant dropout were observed, possibly due to medication side effects or the burden of daily assessments for 12 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Blank | West Virginia University | 304-293-8341 | Melissa.Blank@mail.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2016 | Jun 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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|
| 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. | up to 12 weeks |
| 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. | up to 12 weeks |
| 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 | up to 12 weeks |
| 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. | up to 12 weeks |
| 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). | up to 12 weeks |
| 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). | up to 12 weeks |
| 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. | up to 12 weeks |
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Expired-air Carbon Monoxide | Mean | Standard Deviation | parts per million (ppm) |
|
| Cigarettes Smoked per Day | Mean | Standard Deviation | cigarettes per day |
|
| Years Smoking | Mean | Standard Deviation | years |
|
| Consecutive Days in Opioid Treatment | Mean | Standard Deviation | days |
|
| Cigarette Dependence Score | Fagerstrom Test for Cigarette Dependence scale. Scores ranging from 0-9 with higher scores indicating greater cigarette dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| 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. | Participants that completed the entire 12-week study were compared to those that dropped out before completing to determine potential reasons for attrition. | Posted | Mean | Standard Deviation | percentage of study days | up to 4 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | study days | up to 12 weeks | Study Days | Study Days |
|
|
|
| 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. | Only analyzed data for participants that completed the entire 12-week protocol. | Posted | Mean | Standard Deviation | points on a scale | up to 12 weeks |
|
|
|
|
| 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). | Only analyzed data for participants that completed the entire 12-week protocol. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | number of study days | up to 12 weeks |
|
|
|
| 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. | Only data for participants that completed the entire 12-week protocol were analyzed. | Posted | Mean | Standard Error | cigarettes per day | up to 12 weeks |
|
|
|
|
| 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 | Only analyzed data for participants that completed the entire 12-week protocol. | Posted | Mean | Standard Deviation | units on a scale | up to 12 weeks |
|
|
|
|
| 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. | Only data for participants that completed the entire 12-week protocol were analyzed. | Posted | Mean | Standard Deviation | parts per million (ppm) | up to 12 weeks |
|
|
|
|
| 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). | Only data for participants that completed the entire 12-week protocol were analyzed. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| 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). | Only data for participants that completed the entire 12-week protocol were analyzed. | Posted | Mean | Standard Deviation | units on a scale | up to 12 weeks |
|
|
|
|
| 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. | Only data for participants that completed the entire 12-week protocol were included in analyses. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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 | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D011810 | Quinoxalines |
| Sleep Problems |
|
| Gas/Constipation |
|
| Abnormal Dreams |
|
| Depressed Mood |
|
| Drowsy |
|
| Craving |
|
| Irritability |
|
| Restlessness |
|
| Title | Measurements |
|---|---|
|
|
| Sleep Disturbances |
|
| Gas/Constipation |
|
| Abnormal Dreams |
|
| Depressed Mood |
|
| Drowsy |
|
| Title | Measurements |
|---|---|
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| Week 9 |
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| Week 10 |
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| Week 11 |
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| Week 12 |
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| Restless |
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| Alert |
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| Bored |
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| Calm/Relaxed |
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| Able to Focus |
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| Nervous |
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| Week 8 |
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| Week 12 |
|
| Title | Measurements |
|---|---|
|
| Cocaine |
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| Amphetamine |
|
| Atypical antipsychotics |
|
|
| Week 8 |
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| Week 12 |
|
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| Stayed the same |
|