Trial Outcomes & Findings for Varenicline for Co-occurring Cannabis and Tobacco Use (NCT NCT04595318)

Results Overview

Percentage of the eleven eligible subjects willing to participate

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

Baseline

Results posted on

2024-09-24

Participant Flow

Participants were recruited from an urban, outpatient substance abuse treatment program that offers both intensive behavioral counseling and medication-assisted treatment (MAT) for opioid use disorder. These clinical sites were selected based on being able to successfully recruit and retain participants during prior clinical trials along with an anticipation of high prevalence of persons with frequent cannabis use in the area.

193 individuals in treatment at an outpatient substance use disorder treatment program were screened for eligibility. Of the 186 participants who were not enrolled and randomized, 182 were ineligible and 4 declined to participate. Seven participants were eligible and enrolled and randomized into the eight-week, open-label, within-subject cross over trial.

Participant milestones

Participant milestones
Measure	Standard Clinical Care (SCC) First, Followed by Standard Clinical Care and Varenicline (SCC and VT) Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). This was followed by four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days.	Standard Clinical Care and Varenicline First (SCC + VT), Followed by Standard Clinical Care (SCC) Participants received four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. This was followed by four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).
First Intervention (Four Weeks) STARTED	3	4
First Intervention (Four Weeks) COMPLETED	3	4
First Intervention (Four Weeks) NOT COMPLETED	0	0
Second Intervention (Four Weeks) STARTED	3	4
Second Intervention (Four Weeks) COMPLETED	3	4
Second Intervention (Four Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline for Co-occurring Cannabis and Tobacco Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=7 Participants Participants received either four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program followed by four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT) or four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT) followed by four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program as detailed in the Participant Flow Arm/Group Description
Age, Continuous	49 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Cannabis Craving	43 score on a scale STANDARD_DEVIATION 20 • n=5 Participants
Cannabis Withdrawal	10 score on a scale STANDARD_DEVIATION 11 • n=5 Participants
Quantity of Cannabis Use	77 percentage of days n=5 Participants
Frequency of Cannabis Use	4 Cannabis use per day STANDARD_DEVIATION 0.5 • n=5 Participants
Number of Cigarettes Smoked Per Day	13 Cigarettes smoked per day STANDARD_DEVIATION 9 • n=5 Participants
Number of participants with Toxicology-verified cannabis abstinence	1 Participants n=5 Participants
Number of participants with biochemically-verified tobacco abstinence	1 Participants n=5 Participants
Mean expired carbon monoxide (CO)	9 parts per million (ppm) STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Percentage of the eleven eligible subjects willing to participate

Outcome measures

Outcome measures
Measure	All Study Participants n=11 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Enrollment Rate	7 Participants

SECONDARY outcome

Timeframe: Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Retention rate was determined by the percentage of participants who completed all study visits.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Retention Rate	7 Participants

SECONDARY outcome

Timeframe: Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group)

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Overall medication adherence was calculated as a percentage based on the number of pills prescribed during the study, corrected for the number of pills returned, divided by the period (in days), and multiplied by 100. An aggregate percentage of pills was calculated and reported for all seven study participants.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Overall Medication Adherence	62 Percentage of pills

SECONDARY outcome

Timeframe: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)

Population: While receiving standard clinical care without Varenicline participants were not assessed for Varenicline associated adverse effects. In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of participants with a self-reported adverse event of upset stomach was determined using a structured questionnaire of common varenicline symptoms

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach	5 participants

SECONDARY outcome

Timeframe: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)

Population: While receiving standard clinical care without Varenicline participants were not assessed for Varenicline associated adverse effects. In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of participants with self-reported Treatment-Emergent symptoms of major depressive disorder was determined using the MINI International Neuropsychiatric Interview (M.I.N.I), a short structured diagnostic interview tool used to assess DSM-IV and ICD-10 psychiatric disorders

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder	1 Participants

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF). The MCQ-SF is a valid and reliable, self-report instrument with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Cannabis Craving SCC	34 score on a scale Standard Deviation 20
Cannabis Craving SCC+VT	35 score on a scale Standard Deviation 23

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Cannabis withdrawal was measured by the 15-item version of the Marijuana Withdrawal Checklist (MWC). Participants rated each symptom experienced during their most recent period of marijuana abstinence, based on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A total MWC score was obtained by summing the responses. Possible total scoring ranges from 0 - 45, with 0 signifying no withdrawal symptoms and 45 signifying the most severe withdrawal symptoms.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Cannabis Withdrawal SCC	4 score on a scale Standard Deviation 6
Cannabis Withdrawal SCC+VT	4 score on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The quantity of cannabis use over the prior 14-day period was measured using the Timeline Follow-Back (TLFB) method. TLFS is a method in which participants used a physical calendar to quantify the number of days over a specified period of time (in this study 14 days) during which cannabis was used. An aggregate value for percentage of days of cannabis use was calculated by tabulating the total number of days cannabis was used by all study participants over the prior 14-day period and dividing by the total number of calendar days over this period across the 7 participants (i.e., 14x7=98).

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Quantity of Cannabis Use SCC	82 percentage of days
Quantity of Cannabis Use SCC+VT	60 percentage of days

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The frequency of cannabis use per day was evaluated over the prior 14-day period using the Timeline Follow-Back method (TLFB), a method in which participants used a physical calendar to self-report the number times per days cannabis was used.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Frequency of Cannabis Use SCC	3 Cannabis use per day Standard Deviation 0.4
Frequency of Cannabis Use SCC+VT	2 Cannabis use per day Standard Deviation 0.3

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of cigarettes smoked per day was measured using Timeline Follow-Back (TLFB). TLFB is a method in which participants used a physical calendar to self-report the number of cigarettes smoked per day over the prior 14-day period in order to evaluate ongoing tobacco usage.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Cigarettes Smoked Per Day SCC	5 Cigarettes smoked per day Standard Deviation 7
Number of Cigarettes Smoked Per Day SCC+VT	5 Cigarettes smoked per day Standard Deviation 7

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of participants with Toxicology-verified cannabis abstinence was determined by applying the TLFB method and then biochemically confirming the number of participants with a urine tetrahydrocannabinol (THC) levels less than 50 ng/ml.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Participants With Toxicology-verified Cannabis Abstinence SCC	1 Participants
Number of Participants With Toxicology-verified Cannabis Abstinence SCC+VT	1 Participants

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of participants with biochemically-verified tobacco abstinence was determined by applying the TLFB method and then biochemically verified by measuring participant levels of expired carbon monoxide \< 8 parts per million (CO \< 8ppm). The Bedfont Smokerlyzer carbon monoxide monitor was used in the analysis.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Participants With Biochemically-verified Tobacco Abstinence SCC	2 Participants
Number of Participants With Biochemically-verified Tobacco Abstinence SCC+VT	1 Participants

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

Mean expired carbon monoxide (CO) per participant was measured using the Bedfont Smokerlyzer carbon monoxide monitor. Results reported in mean parts per million (ppm)

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Mean Expired Carbon Monoxide SCC	13 parts per million (ppm) Standard Deviation 9
Mean Expired Carbon Monoxide SCC+VT	14 parts per million (ppm) Standard Deviation 11

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: In a deviation from the trial design, one participant completed SCC alone for two weeks, then SCC+VT for four weeks, followed by SCC alone for two weeks.

The number of participants with treatment-emergent suicidal ideation events was determined using the Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime as well as during the past 3 months. An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions to the final three questions indicates high-risk.

Outcome measures

Outcome measures
Measure	All Study Participants n=7 Participants Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). Participants also received four weeks of SCC plus varenicline treatment (SCC+VT). Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Of the 7 participants on study, three participants were randomized to begin with four weeks of SCC followed by four weeks of SCC+VT and four participants were randomized to begin with four weeks of SCC+VT followed by four weeks of SCC only.
Number of Participants With Treatment-Emergent Suicidal Ideation Events SCC	0 Participants
Number of Participants With Treatment-Emergent Suicidal Ideation Events SCC+VT	0 Participants

Adverse Events

Standard Clinical Care (SCC )

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Clinical Care and Varenicline (SCC + VT)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Clinical Care (SCC ) n=7 participants at risk Participants received four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).	Standard Clinical Care and Varenicline (SCC + VT) n=7 participants at risk Participants received four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC included individual counseling, at least once a month, that used motivational and cognitive behavioral strategies, addressed cannabis or tobacco use, as needed, and was delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a four-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days.
Nervous system disorders insomnia	0.00% 0/7 • Week 4 and Week 8	57.1% 4/7 • Number of events 4 • Week 4 and Week 8
Gastrointestinal disorders upset stomach	0.00% 0/7 • Week 4 and Week 8	71.4% 5/7 • Number of events 5 • Week 4 and Week 8

Additional Information

Dr. Shadi Nahvi

Montefiore Health System

Phone: 718 920 5379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place