Marijuana Use, Smoking Cessation
Conditions
Keywords
smoking cessation, marijuana use
Brief summary
Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. A recent study found that 25% of callers to state quitlines said they were using marijuana and 44% of those were interested in quitting or cutting back their marijuana use (in addition to wanting to quit smoking). The investigators propose to develop an integrated intervention for co-users of marijuana and tobacco to be delivered via state-funded quitlines. The investigators will incorporate key elements of an evidence-based brief behavioral intervention called 'The Marijuana Check-Up' into the tobacco quitline treatment. The investigators will evaluate the feasibility, acceptability and preliminary effects of the new intervention in a small randomized pilot study with 100 co-users recruited from four participating state quitlines. Outcomes measured at 3 months post randomization will include tobacco abstinence (biochemically verified) and days used marijuana. The investigators hypothesize that the intervention will: (1) be feasible to deliver (measured by coach treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments into the study and call completion numbers); (3) increase tobacco cessation rates compared with standard quitline treatment; (4) increase co-users motivation to change MJ use; and (5) produce greater reduction in days using MJ compared with standard quitline treatment. The proposed brief behavioral intervention addressing co-use may increase quitline callers' chances of achieving and maintaining tobacco abstinence and increase participants' motivation to reduce marijuana use. As non-medicinal marijuana use becomes common and legal in more states, a low touch phone and web-based intervention for co-users of marijuana and tobacco could improve health outcomes for many. Findings will inform development of scalable public health intervention strategies for co-users easily implemented across quitlines.
Detailed description
We proposed to adapt a brief motivational intervention for cannabis (CB)) users who call tobacco quitlines for help quitting tobacco. We plan to recruit 100 adult co-users of tobacco and CB from four state quitlines that have legalized non-medicinal CB user. Quitline registration staff screen participants for current use of CB and interest in learning about CB use. Interested co-users will then talk to a specially trained quit coach who will ask additional eligibility questions, obtain informed consent from eligible participants, conduct a baseline assessment, randomize individuals to one of two groups and deliver the first counseling session according to the assigned intervention. Randomization is automated using the pre-programmed random number table (stratified by state and gender) built into the Quitline coaching application. Individuals are randomly assigned to receive the standard Quitline or the integrated CB and quitline intervention. All participants receive the standard quitline treatment: 4-5 counseling sessions delivered over the phone, mailed materials, access to the text messaging and web-based program plus cessation medications (nicotine replacement therapy; NRT) and unlimited calls into the quitline for help between calls. Quit coaches will deliver the CB intervention during the tobacco quitline calls for the intervention group. Study participants complete surveys at baseline and 3-months. We will compare groups on treatment engagement (calls completed) and outcomes at 3 months (tobacco abstinence and change in days used CB). Our proposed sample size of 100 (50 per group) is sufficient to achieve our study aims of assessing the feasibility, acceptability and preliminary effectiveness of the new integrated intervention compared with standard quitline treatment.
Interventions
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) 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).
Sponsors
Study design
Intervention model description
A single arm pilot followed by a 2 arm randomized control trial
Eligibility
Inclusion criteria
* daily use of 5 or more tobacco cigarettes * aged 21 and older * recruited from participating state quitlines (AK, DC, OR, WA) * provides an email address * wants to quit tobacco in the next 30 days * used cannabis on 9 or more days in the past 30 days
Exclusion criteria
* unable to speak and read English * have limited access to a telephone * pregnant or post-partum (because they are not offered the standard QL program) * self-reported schizophrenia * all cannabis use is recommended by a doctor or other healthcare professional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Calls Completed | from program enrollment up to 3 months post-enrollment | Number of calls completed (collected during treatment and finalized at end of study) |
| Tobacco Use | 3 months | Cessation from tobacco use 7-day point prevalent abstinence |
| Satisfaction With Treatments | 3 months | 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. |
| Readiness to Change Marijuana Use | 3 months | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Verification of Tobacco Abstinence | 3 months | Self-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes. |
| Marijuana Use | 3 months | Number of days used in the past 30 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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). | 53 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 2 Study | Did not take any coaching calls | 4 | 0 |
| Phase 2 Study | Lost to Follow-up | 15 | 15 |
| Phase 2 Study | Withdrawal by Subject | 0 | 1 |
| Pilot Phase 1 of Study | Randomized but ineligible | 0 | 1 |
| Pilot Phase 1 of Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Quitline Treatment As Usual (TAU) | Total | QL Marijuana Check-Up Intervention (QL-MJCU). |
|---|---|---|---|
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 14.3 | 51.7 Years STANDARD_DEVIATION 13.6 | 52.9 Years STANDARD_DEVIATION 13 |
| Cannabis Use Disorder Identification Test | 10.2 units on a scale STANDARD_DEVIATION 4.9 | 10.1 units on a scale STANDARD_DEVIATION 4.7 | 10.1 units on a scale STANDARD_DEVIATION 4.4 |
| Cigarettes Per Day | 17.4 number of cigarettes per day STANDARD_DEVIATION 8.1 | 16.3 number of cigarettes per day STANDARD_DEVIATION 7.7 | 15.2 number of cigarettes per day STANDARD_DEVIATION 7.2 |
| Daily Cannabis Use (20+ Days in Last 30 Days) | 41 Participants | 80 Participants | 39 Participants |
| Days of Cannabis Use Within Last 30 Days | 25.7 Days STANDARD_DEVIATION 6.8 | 24.8 Days STANDARD_DEVIATION 7.1 | 24.0 Days STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 100 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Poitive Screening for Depression (PHQ-2) | 20 Participants | 34 Participants | 14 Participants |
| POsitive Screening for Anxiety (GAD-2) | 20 Participants | 34 Participants | 14 Participants |
| PSS-4 | 6.8 units on a scale STANDARD_DEVIATION 3.5 | 6.2 units on a scale STANDARD_DEVIATION 3.2 | 5.7 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 75 Participants | 38 Participants |
| Readiness to Quit Cannabis | 3.4 units on a scale STANDARD_DEVIATION 3.2 | 3.3 units on a scale STANDARD_DEVIATION 3.2 | 3.3 units on a scale STANDARD_DEVIATION 3.2 |
| Readiness to Reduce Cannabis | 4.2 units on a scale STANDARD_DEVIATION 3.3 | 4.2 units on a scale STANDARD_DEVIATION 3.3 | 4.1 units on a scale STANDARD_DEVIATION 3.3 |
| Region of Enrollment United States | 49 participants | 102 participants | 53 participants |
| Sex: Female, Male Female | 25 Participants | 51 Participants | 26 Participants |
| Sex: Female, Male Male | 24 Participants | 51 Participants | 27 Participants |
| Time to First Cigarette Use 31-60 Minutes | 7 Participants | 13 Participants | 6 Participants |
| Time to First Cigarette Use 6-30 minutes | 26 Participants | 48 Participants | 22 Participants |
| Time to First Cigarette Use More than 60 Minutes | 2 Participants | 7 Participants | 5 Participants |
| Time to First Cigarette Use Within 5 Minutes | 14 Participants | 34 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Number of Calls Completed
Number of calls completed (collected during treatment and finalized at end of study)
Time frame: from program enrollment up to 3 months post-enrollment
Population: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Number of Calls Completed | 123 Total number of calls |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Number of Calls Completed | 141 Total number of calls |
Readiness to Change Marijuana Use
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?
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Readiness to Change Marijuana Use | 3.3 units on a scale | Standard Deviation 3.4 |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Readiness to Change Marijuana Use | 2.9 units on a scale | Standard Deviation 2.9 |
Satisfaction With Treatments
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Satisfaction With Treatments | 28 participants |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Satisfaction With Treatments | 30 participants |
Tobacco Use
Cessation from tobacco use 7-day point prevalent abstinence
Time frame: 3 months
Population: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Tobacco Use | 14 Participants |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Tobacco Use | 13 Participants |
Biochemical Verification of Tobacco Abstinence
Self-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes.
Time frame: 3 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Biochemical Verification of Tobacco Abstinence | 2 Participants |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Biochemical Verification of Tobacco Abstinence | 5 Participants |
Marijuana Use
Number of days used in the past 30
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Marijuana Use | 23.2 days | Standard Deviation 10 |
| QL Marijuana Check-Up Intervention (QL-MJCU). | Marijuana Use | 19.1 days | Standard Deviation 11.8 |