Trial Outcomes & Findings for Developing a Smoking Cessation Intervention for Methadone Maintained Smokers (NCT NCT01393392)

Last Updated: 2018-09-06

Results Overview

Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of \<8 parts per million.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

87 participants

Primary outcome timeframe

during the previous seven days at three months post baseline

Results posted on

2018-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Intensive, Tailored Intervention Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Overall Study STARTED	44	43
Overall Study COMPLETED	33	24
Overall Study NOT COMPLETED	11	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=43 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).	Total n=84 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 11 • n=5 Participants	42 years STANDARD_DEVIATION 10 • n=7 Participants	43 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: during the previous seven days at three months post baseline

Population: Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.

Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of \<8 parts per million.

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence	3 Participants	0 Participants

SECONDARY outcome

Timeframe: during the previous seven days at three months post baseline

Self-reported, median number of cigarettes per day during the previous seven days

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Median Number of Cigarettes Participants Smoked Per Day During the Past Week	6 cigarettes Interval 4.0 to 15.0	10 cigarettes Interval 5.0 to 20.0

SECONDARY outcome

Timeframe: During the period between baseline and three months post enrollment

Self-reported, smoke free for 24 hours or more since baseline (yes/no)

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Number of Participants Who Experienced Any Quit Attempts Since Baseline	21 Participants	14 Participants

SECONDARY outcome

Timeframe: during the previous seven days at six months post baseline

Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of \<8 parts per million.

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence	1 Participants	0 Participants

SECONDARY outcome

Timeframe: during the previous seven days at six months post baseline

Self-reported, median number of cigarettes per day during the previous seven days

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Median Number of Cigarettes Smoked Per Day During the Past Week	8 cigarettes Interval 4.0 to 14.0	10 cigarettes Interval 6.0 to 20.0

SECONDARY outcome

Timeframe: during the period between baseline and six months post-enrollment

Self-reported, smoke free for 24 hours or more since baseline (yes/no)

Outcome measures

Outcome measures
Measure	Intensive, Tailored Intervention n=41 Participants Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=42 Participants Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Number of Participants Who Experienced Any Quit Attempts Since Enrollment	23 Participants	17 Participants

Adverse Events

Intensive, Tailored Intervention

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Control Intervention

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intensive, Tailored Intervention n=44 participants at risk Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=43 participants at risk Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Renal and urinary disorders Death	0.00% 0/44 • 2.5 years AEs assessed at each counseling and research visit.	2.3% 1/43 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.

Other adverse events

Additional Information

Dr. Nina Cooperman

Rutgers Robert Wood Johnson Medical School

Phone: 732-235-8569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intensive, Tailored Intervention n=44 participants at risk Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.	Control Intervention n=43 participants at risk Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Respiratory, thoracic and mediastinal disorders cough up blood	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders leg pain	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders nausea	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders insomnia	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Psychiatric disorders depression	11.4% 5/44 • Number of events 5 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders increased alcohol use	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Skin and subcutaneous tissue disorders itching/irritation at patch site	13.6% 6/44 • Number of events 6 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders jittery/agitated/irritable	9.1% 4/44 • Number of events 4 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Infections and infestations tooth infection	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders headache	6.8% 3/44 • Number of events 3 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders vivid dreams	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders hemorrhoids	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders chest discomfort/pain	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders increased appetite	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Musculoskeletal and connective tissue disorders back pain	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders Extremely high expired carbon monoxide level	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Respiratory, thoracic and mediastinal disorders shortness of breath	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders sores on tongue	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Psychiatric disorders suicidal ideation	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Respiratory, thoracic and mediastinal disorders pneumonia	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders insomnia/restless sleep	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders vertigo	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
Psychiatric disorders anxiety	4.5% 2/44 • Number of events 2 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders appendicitis	0.00% 0/44 • 2.5 years AEs assessed at each counseling and research visit.	2.3% 1/43 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.
Infections and infestations bronchitis	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.
General disorders cough	2.3% 1/44 • Number of events 1 • 2.5 years AEs assessed at each counseling and research visit.	0.00% 0/43 • 2.5 years AEs assessed at each counseling and research visit.