Cannabis UseNCT04174963
An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
A study testing eToke + TPsy in people with Cannabis Use and Psychiatric Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Cannabis use disorders are common among young adults in psychiatric treatment. Unfortunately, cannabis use can result in deleterious consequences for those in treatment, including developing more severe psychopathology and poorer treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Psychiatric Disorder
- What is being tested?
- eToke + TPsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 28 years of age
- Report using cannabis 2 or more times per week
- English speaking
- Have a telephone that can receive text-messages
- Receive psychiatric treatment in the Young Adult Behavioral Health Program or Partial Program at Rhode Island Hospital.
- Be at high risk for psychosis according to mental health guidelines
Who cannot join
- Psychiatric symptoms severe enough to preclude meaningful consent or participation, as determined by the treatment psychiatrist and research team
- Current clinical diagnosis of mental retardation or pervasive developmental disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Cannabis use disorders are common among young adults in psychiatric treatment. Unfortunately, cannabis use can result in deleterious consequences for those in treatment, including developing more severe psychopathology and poorer treatment outcomes. Brief, electronic interventions for cannabis use have been developed for young adults. An example of a frequently used brief electronic intervention for cannabis users is e-Toke. e-Toke can be completed on a computer, tablet or phone, and has been shown to improve motivation to engage in substance use treatment among college students. However, e-Toke is less useful in decreasing the actual frequency of cannabis use. Additionally, e-toke is not tailored to young adults in psychiatric treatment. In this study, the investigators will develop and test a text messaging intervention that can be easily added to the popular computerized intervention e-Toke. The research staff hope the intervention will improve motivation to decrease cannabis use, and decrease the frequency of cannabis use, among young adults in psychiatric outpatient treatment. The text messages will be developed by, and tailored to, young adults in psychiatric treatment and texts will address motivations and barriers to reducing cannabis use in the context of psychiatric disorders. If the text message intervention is found to be an effective addition to e-Toke, this approach can be tested in a larger study, and then disseminated to other young adults in psychiatric treatment.
Read the detailed description
Young adults 18-28 years old have the highest prevalence rates of cannabis use. Unfortunately, the biological consequences of cannabis use are more severe compared to older adults. These specific biological consequences are due to the negative effect cannabis use has on neurological maturation permanently impacting motivation, impulsivity, and future addictive behavior. The neurological effects of cannabis use are most disruptive to young adults living with psychiatric illness. In the Young Adult Behavioral Health Program at Rhode Island Hospital, 68% of patient's ages 18-28 who are in treatment for psychiatric disorders have used cannabis, and of those that have used 24% use cannabis daily or weekly. These high rates of cannabis use result in deleterious consequences, including developing more severe psychopathology, increased rates of psychosis, impairments in educational achievement and occupational obtainment, poorer treatment outcomes, poorer adherence to treatment, and increased treatment costs. Motivational Enhancement Therapy (MET) is an efficacious strategy for improving readiness to decrease cannabis use and increase motivation to engage in substance use treatment. The MET program entitled eToke (also known as E-Check-Up to Go), is a popular, frequently used, and previously investigated brief computerized intervention with efficacy in improving readiness for change among college students. In this study, the investigators propose to develop a text messaging intervention that will accompany eToke and will be tailored to young adults with psychiatric illness with cannabis use disorders. This intervention will be called e-Toke+TPsy. The text messages used in this intervention will contain information about the deleterious consequences of cannabis use, motivational material about the specific risks of cannabis use for young adults in psychiatric treatment. Texts will also contain behavioral skill building exercises to help reduce the frequency of cannabis use. The material for the text messages will be developed with input from young adults receiving psychiatric care at the Young Adult Behavioral Health Program. Text messages will also be informed by the Information, Motivation, and Behavioral Skills Theory of learning (IMB Theory).
- Conditions
- Cannabis Use, Psychiatric Disorder
- Being tested
- eToke + TPsy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eToke + TPsyBehavioural
Combination of brief computerized intervention (eToke) with Information-Motivation-Behavior based text messages tailored to young adults in psychiatric treatment
| Study group | Role | What they receive |
|---|---|---|
| eToke + TPsy | Experimental | All participants will receive the intervention (eToke+TPsy). The intervention consists of eToke (a brief computerized intervention that uses motivational enhancement therapy to improve readiness to decrease cannabis use and increase motivation to engage in substance use treatment) AND 6-8 interactive text messages regarding cannabis use reduction over 4 weeks . Text messages will contain written content, and queries, as well as links to publicly available websites and YouTube videos. Receives: Behavioral: eToke + TPsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reported Frequency of Cannabis Use
This self-report will be obtained using an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) nine times throughout the duration of the study. The abbreviated ASSIST will be administered at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11 of the study.
Measured: Assessed at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11
Change in Self-reported Motivation to Reduce Cannabis Use (SOCRATES)
Motivation to change substance use will be assessed using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) adapted for cannabis use (19-item questionnaires that assess recognition, ambivalence, and taking steps). Change will be assessed from baseline to 12-weeks follow-up.
Measured: Assessed at baseline and 12 weeks
Change in Self-reported Motivation to Reduce Cannabis Use (Readiness Ruler)
Motivation to change substance use will be assessed using the Readiness Ruler (rates degree of readiness to cut down ranging from 1 to 10 for twelve different substance categories). Change will be assessed from baseline to 12-weeks follow-up.
Measured: Assessed at baseline and 12 weeks
Change in Self-reported Motivation to Reduce Cannabis Use (DBI)
Motivation to change substance use will be assessed using the Decisional Balance Inventory (16-item measure of the pros and cons of substance use). Change will be assessed from baseline to 12-weeks follow-up.
Measured: Assessed at baseline and 12 weeks
Secondary outcomes (2)
Change in Self-reported Psychiatric Symptoms
Mental health issues will be assessed by the Brief Symptom Inventory (BSI-18), which yields primary symptom scales and global indices and has norms for adolescents and adults. The reliability, validity, and utility of the BSI instrument have been tested in more than 400 research studies. Internal consistency for the sub-scales (dimensions) range from .71 to .85. Each item will be reported on a scale of 0 to 4, with higher scores indicating greater mental health symptoms. Change will be assessed from baseline to 12-weeks follow-up.
Measured: Assessed at baseline and 12 weeks
Change in Self-reported Self-efficacy to Reduce Cannabis Use (SCQ-8)
Self-efficacy will be assessed with the Situational Confidence Questionnaire (SCQ-8), an 8-item measure that assesses an individual's confidence in being able to resist the urge to use a given substance across different situations. The SCQ has been demonstrated reliable and valid. Each item is reported on a scale of 0 to 100, with higher scores indicating greater self-efficacy to resist using cannabis. Change will be assessed from baseline to 12-weeks follow-up.
Measured: Assessed at baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Nov 2019
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: Based on Initial findings and input from other researchers in the field, the investigators and sponsor decided to end this study and begin work on an updated version of this research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Whiteley, Rhode Island Hospital
- Investigators
- Laura Whiteley, MD, Principal investigator, Rhode Island HospitalLarry Brown, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174963
- Sponsor's protocol ID
- 1445964
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elliott JC, Carey KB. Correcting exaggerated marijuana use norms among college abstainers: a preliminary test of a preventive intervention. J Stud Alcohol Drugs. 2012 Nov;73(6):976-80. doi: 10.15288/jsad.2012.73.976.
PubMed 23036216Miller WR, Tonigan JS. Assessing drinkers' motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors 10(20): 81-89, 1996.
Migneault JP, Pallonen UE, Velicer WF. Decisional balance and stage of change for adolescent drinking. Addict Behav. 1997 May-Jun;22(3):339-51. doi: 10.1016/s0306-4603(96)00252-3.
PubMed 9183504Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
PubMed 6622612Kirisci L, Moss HB, Tarter RE. Psychometric evaluation of the Situational Confidence Questionnaire in adolescents: fitting a graded item response model. Addict Behav. 1996 May-Jun;21(3):303-17. doi: 10.1016/0306-4603(95)00060-7.
PubMed 8883482WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
PubMed 12199834
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
- ClinicalTrials.gov ID
- NCT04174963
- Acronym / sponsor ID
- 1445964
- Conditions
- Cannabis Use, Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on Initial findings and input from other researchers in the field, the investigators and sponsor decided to end this study and begin work on an updated version of this research.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cannabis use disorders are common among young adults in psychiatric treatment. Unfortunately, cannabis use can result in deleterious consequences for those in treatment, including developing more severe psychopathology and poorer treatment outcomes. Brief, electronic interventions for cannabis use have been developed for young adults. An example of a frequently used brief electronic intervention for cannabis users is e-Toke. e-Toke can be completed on a computer, tablet or phone, and has been shown to improve motivation to engage in substance use treatment among college students. However, e-Toke is less useful in decreasing the actual frequency of cannabis use. Additionally, e-toke is not tailored to young adults in psychiatric treatment. In this study, the investigators will develop and test a text messaging intervention that can be easily added to the popular computerized intervention e-Toke. The research staff hope the intervention will improve motivation to decrease cannabis use, and decrease the frequency of cannabis use, among young adults in psychiatric outpatient treatment. The text messages will be developed by, and tailored to, young adults in psychiatric treatment and texts will address motivations and barriers to reducing cannabis use in the context of psychiatric disorders. If the text message intervention is found to be an effective addition to e-Toke, this approach can be tested in a larger study, and then disseminated to other young adults in psychiatric treatment.
Detailed description
Young adults 18-28 years old have the highest prevalence rates of cannabis use. Unfortunately, the biological consequences of cannabis use are more severe compared to older adults. These specific biological consequences are due to the negative effect cannabis use has on neurological maturation permanently impacting motivation, impulsivity, and future addictive behavior. The neurological effects of cannabis use are most disruptive to young adults living with psychiatric illness. In the Young Adult Behavioral Health Program at Rhode Island Hospital, 68% of patient's ages 18-28 who are in treatment for psychiatric disorders have used cannabis, and of those that have used 24% use cannabis daily or weekly. These high rates of cannabis use result in deleterious consequences, including developing more severe psychopathology, increased rates of psychosis, impairments in educational achievement and occupational obtainment, poorer treatment outcomes, poorer adherence to treatment, and increased treatment costs. Motivational Enhancement Therapy (MET) is an efficacious strategy for improving readiness to decrease cannabis use and increase motivation to engage in substance use treatment. The MET program entitled eToke (also known as E-Check-Up to Go), is a popular, frequently used, and previously investigated brief computerized intervention with efficacy in improving readiness for change among college students. In this study, the investigators propose to develop a text messaging intervention that will accompany eToke and will be tailored to young adults with psychiatric illness with cannabis use disorders. This intervention will be called e-Toke+TPsy. The text messages used in this intervention will contain information about the deleterious consequences of cannabis use, motivational material about the specific risks of cannabis use for young adults in psychiatric treatment. Texts will also contain behavioral skill building exercises to help reduce the frequency of cannabis use. The material for the text messages will be developed with input from young adults receiving psychiatric care at the Young Adult Behavioral Health Program. Text messages will also be informed by the Information, Motivation, and Behavioral Skills Theory of learning (IMB Theory).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eToke + TPsy | Experimental | Behavioral: eToke + TPsyAll participants will receive the intervention (eToke+TPsy). The intervention consists of eToke (a brief computerized intervention that uses motivational enhancement therapy to improve readiness to decrease cannabis use and increase motivation to engage in substance use treatment) AND 6-8 interactive text messages regarding cannabis use reduction over 4 weeks . Text messages will contain written content, and queries, as well as links to publicly available websites and YouTube videos. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 - 28 years of age
- Report using cannabis 2 or more times per week
- English speaking
- Have a telephone that can receive text-messages
- Receive psychiatric treatment in the Young Adult Behavioral Health Program or Partial Program at Rhode Island Hospital.
Key exclusion criteria (2 listed)
- Psychiatric symptoms severe enough to preclude meaningful consent or participation, as determined by the treatment psychiatrist and research team
- Current clinical diagnosis of mental retardation or pervasive developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eToke + TPsyCombination of brief computerized intervention (eToke) with Information-Motivation-Behavior based text messages tailored to young adults in psychiatric treatment | Behavioural | eToke + TPsy |
Primary outcome
Change in Self-reported Frequency of Cannabis Use
Time frame: Assessed at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11
This self-report will be obtained using an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) nine times throughout the duration of the study. The abbreviated ASSIST will be administered at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11 of the study.
Change in Self-reported Motivation to Reduce Cannabis Use (SOCRATES)
Time frame: Assessed at baseline and 12 weeks
Motivation to change substance use will be assessed using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) adapted for cannabis use (19-item questionnaires that assess recognition, ambivalence, and taking steps). Change will be assessed from baseline to 12-weeks follow-up.
Change in Self-reported Motivation to Reduce Cannabis Use (Readiness Ruler)
Time frame: Assessed at baseline and 12 weeks
Motivation to change substance use will be assessed using the Readiness Ruler (rates degree of readiness to cut down ranging from 1 to 10 for twelve different substance categories). Change will be assessed from baseline to 12-weeks follow-up.
Change in Self-reported Motivation to Reduce Cannabis Use (DBI)
Time frame: Assessed at baseline and 12 weeks
Motivation to change substance use will be assessed using the Decisional Balance Inventory (16-item measure of the pros and cons of substance use). Change will be assessed from baseline to 12-weeks follow-up.
2 secondary outcomes
Change in Self-reported Psychiatric Symptoms
Time frame: Assessed at baseline and 12 weeks
Change in Self-reported Self-efficacy to Reduce Cannabis Use (SCQ-8)
Time frame: Assessed at baseline and 12 weeks
Results and safety
The study was stopped early (reason given: Based on Initial findings and input from other researchers in the field, the investigators and sponsor decided to end this study and begin work on an updated version of this research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 23036216Elliott JC, Carey KB. Correcting exaggerated marijuana use norms among college abstainers: a preliminary test of a preventive intervention. J Stud Alcohol Drugs. 2012 Nov;73(6):976-80. doi: 10.15288/jsad.2012.73.976.
- BackgroundMiller WR, Tonigan JS. Assessing drinkers' motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors 10(20): 81-89, 1996.
- Background: PubMed 9183504Migneault JP, Pallonen UE, Velicer WF. Decisional balance and stage of change for adolescent drinking. Addict Behav. 1997 May-Jun;22(3):339-51. doi: 10.1016/s0306-4603(96)00252-3.
- Background: PubMed 6622612Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
- Background: PubMed 8883482Kirisci L, Moss HB, Tarter RE. Psychometric evaluation of the Situational Confidence Questionnaire in adolescents: fitting a graded item response model. Addict Behav. 1996 May-Jun;21(3):303-17. doi: 10.1016/0306-4603(95)00060-7.
- Background: PubMed 12199834WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Whiteley, MD principal investigator
Rhode Island Hospital
Larry Brown, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eToke + TPsy in people with Cannabis Use and Psychiatric Disorder, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Based on Initial findings and input from other researchers in the field, the investigators and sponsor decided to end this study and begin work on an updated version of this research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Frequency of Cannabis Use (time frame: Assessed at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174963, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.