Trial Outcomes & Findings for Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco (NCT NCT04737772)
NCT ID: NCT04737772
Last Updated: 2025-02-27
Results Overview
Number of calls completed (collected during treatment and finalized at end of study)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
from program enrollment up to 3 months post-enrollment
Results posted on
2025-02-27
Participant Flow
Participant milestones
| Measure |
Standard Quitline Treatment As Usual (TAU)
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Phase 2 Study
STARTED
|
53
|
54
|
|
Phase 2 Study
COMPLETED
|
34
|
38
|
|
Phase 2 Study
NOT COMPLETED
|
19
|
16
|
|
Pilot Phase 1 of Study
STARTED
|
0
|
12
|
|
Pilot Phase 1 of Study
COMPLETED
|
0
|
10
|
|
Pilot Phase 1 of Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Standard Quitline Treatment As Usual (TAU)
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Phase 2 Study
Lost to Follow-up
|
15
|
15
|
|
Phase 2 Study
Withdrawal by Subject
|
0
|
1
|
|
Phase 2 Study
Did not take any coaching calls
|
4
|
0
|
|
Pilot Phase 1 of Study
Withdrawal by Subject
|
0
|
1
|
|
Pilot Phase 1 of Study
Randomized but ineligible
|
0
|
1
|
Baseline Characteristics
Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco
Baseline characteristics by cohort
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=49 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=53 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
52.9 Years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
51.7 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
53 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Poitive Screening for Depression (PHQ-2)
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
POsitive Screening for Anxiety (GAD-2)
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
PSS-4
|
6.8 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Cigarettes Per Day
|
17.4 number of cigarettes per day
STANDARD_DEVIATION 8.1 • n=5 Participants
|
15.2 number of cigarettes per day
STANDARD_DEVIATION 7.2 • n=7 Participants
|
16.3 number of cigarettes per day
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Time to First Cigarette Use
Within 5 Minutes
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Time to First Cigarette Use
6-30 minutes
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Time to First Cigarette Use
31-60 Minutes
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Time to First Cigarette Use
More than 60 Minutes
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Days of Cannabis Use Within Last 30 Days
|
25.7 Days
STANDARD_DEVIATION 6.8 • n=5 Participants
|
24.0 Days
STANDARD_DEVIATION 7.4 • n=7 Participants
|
24.8 Days
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Daily Cannabis Use (20+ Days in Last 30 Days)
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Cannabis Use Disorder Identification Test
|
10.2 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Readiness to Quit Cannabis
|
3.4 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Readiness to Reduce Cannabis
|
4.2 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: from program enrollment up to 3 months post-enrollmentPopulation: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed
Number of calls completed (collected during treatment and finalized at end of study)
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=49 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=53 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Number of Calls Completed
|
123 Total number of calls
|
141 Total number of calls
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed
Cessation from tobacco use 7-day point prevalent abstinence
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=49 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=53 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Tobacco Use
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.
Satisfaction with treatments elicited via outcome survey questions. Question asked, "Overall, how satisfied were you with the Quitline? Would you say…" Answer responses were: VERY SATISFIED; SATISFIED; SOMEWHAT SATISFIED; SOMEWHAT DISSATISFIED; DISSATISFIED; VERY DISSATISFIED; I PREFER NOT TO ANSWER. The outcome measure reported the number of those who responded as being somewhat satisfied or higher.
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=34 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=37 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Satisfaction With Treatments
|
28 participants
|
30 participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.
1-10 scale, where 1 signifies low readiness. On the 3-months post-outcomes survey participants were asked: "On a scale of 1 to 10 where 1 is not at all ready and 10 is very ready, how ready are you to reduce how much cannabis you use?"
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=34 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=38 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Readiness to Change Marijuana Use
|
3.3 units on a scale
Standard Deviation 3.4
|
2.9 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Twenty-seven participants reported being quit from tobacco at their follow-up and were mailed a cotinine test kit. Ten of those participants returned results via an emailed photo of their results strip
Self-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes.
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=3 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=7 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Biochemical Verification of Tobacco Abstinence
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.
Number of days used in the past 30
Outcome measures
| Measure |
Standard Quitline Treatment As Usual (TAU)
n=34 Participants
State quitline treatment as usual
Behavioral: Quitline treatment as usual: TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
|
QL Marijuana Check-Up Intervention (QL-MJCU).
n=38 Participants
Newly developed intervention for co-users of marijuana and tobacco.
QL Marijuana Check-Up intervention (QL-MJCU): QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
|
|---|---|---|
|
Marijuana Use
|
23.2 days
Standard Deviation 10.0
|
19.1 days
Standard Deviation 11.8
|
Adverse Events
Standard Quitline Treatment As Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
QL Marijuana Check-Up Intervention (QL-MJCU).
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place