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| Name | Class |
|---|---|
| University of Washington | OTHER |
| SRI International | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Active Comparator | State quitline treatment as usual |
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| QL Marijuana Check-Up intervention (QL-MJCU). | Experimental | Newly developed intervention for co-users of marijuana and tobacco. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: Quitline treatment as usual | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Calls Completed | Number of calls completed (collected during treatment and finalized at end of study) | from program enrollment up to 3 months post-enrollment |
| Tobacco Use | Cessation from tobacco use 7-day point prevalent abstinence | 3 months |
| 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. | 3 months |
| 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?" | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Marijuana Use |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kelly M Carpenter, PhD | Consumer Wellness Solutions (Optum) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optum | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38873657 | Derived | Carpenter KM, Walker DD, Mullis K, Berlin HM, Short E, Javitz HS, Carlini BH. Testing a Brief Quitline Intervention for Tobacco Cannabis Co-Users: A Randomized Controlled Pilot Study. Tob Use Insights. 2024 Jun 12;17:1179173X241261302. doi: 10.1177/1179173X241261302. eCollection 2024. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 2 Study |
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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 | Apr 19, 2024 |
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A single arm pilot followed by a 2 arm randomized control trial
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| QL Marijuana Check-Up intervention (QL-MJCU) | Behavioral | 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). |
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Number of days used in the past 30
| 3 months |
| 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). |
| COMPLETED |
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| NOT COMPLETED |
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| Pilot Phase 1 of Study |
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We had 1 participant in the experimental group who withdrew from the study and 4 participants in the control group who did not take any coaching calls; therefore, we did not analyze their data or include them in the final dataset.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Poitive Screening for Depression (PHQ-2) | Count of Participants | Participants |
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| POsitive Screening for Anxiety (GAD-2) | Count of Participants | Participants |
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| PSS-4 | Participants are asked 4 questions regarding perceived stress (PSS-4=Perceived Stress Scale 4) on a scale from 0-4 with a total score of "0" being the lowest (best outcome) and a total score of "16" being the highest (worse outcome). | Mean | Standard Deviation | units on a scale |
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| Cigarettes Per Day | Mean | Standard Deviation | number of cigarettes per day |
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| Time to First Cigarette Use | Many research studies have reported that the time to first cigarette (TTFC) of the day is one of the strongest indicators of nicotine dependence. | Count of Participants | Participants |
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| Days of Cannabis Use Within Last 30 Days | Mean | Standard Deviation | Days |
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| Daily Cannabis Use (20+ Days in Last 30 Days) | Count of Participants | Participants |
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| Cannabis Use Disorder Identification Test | The CUDIT (Cannabis Use Disorder Identification Test) was designed for self-administration and is scored by adding each of the 8 items. Questions 1-7 are scored on a 0-4 scale. Question 8 is scored 0, 2 or 4. Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required. | Mean | Standard Deviation | units on a scale |
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| Readiness to Quit Cannabis | The Readiness to Quit Cannabis measures an individual's perceived readiness to quit cannabis use based on a scale from 1-10 with 1 being not ready at all and 10 being very ready. | Mean | Standard Deviation | units on a scale |
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| Readiness to Reduce Cannabis | The Readiness to Reduce Cannabis measures an individual's perceived readiness to reduce cannabis use based on a scale from 1-10 with 1 being not ready at all and 10 being very ready. | Mean | Standard Deviation | units on a scale |
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| 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 | Number of Calls Completed | Number of calls completed (collected during treatment and finalized at end of study) | 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed | Posted | Number | Total number of calls | from program enrollment up to 3 months post-enrollment |
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| Primary | Tobacco Use | Cessation from tobacco use 7-day point prevalent abstinence | 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed | Posted | Count of Participants | Participants | 3 months |
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| Primary | 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. | 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. | Posted | Number | participants | 3 months |
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| Primary | 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?" | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | 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. | 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 | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Marijuana Use | Number of days used in the past 30 | 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. | Posted | Mean | Standard Deviation | days | 3 months |
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N/A - not assessed
Adverse events were not collected. Upon study initiation, there was a reporting system to collect adverse events; however that was quickly discontinued by the reporting team. The outcomes survey also did not collect information on adverse events; therefore, there is no information regarding adverse events to share.
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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 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helena Berlin | RVO Health | 702-620-4965 | hberlin@rvohealth.com |
| Apr 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000074609 | Marijuana Use |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6-30 minutes |
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| 31-60 Minutes |
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| More than 60 Minutes |
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