Cannabis Use DisorderNCT03432013
Affective Management Training for Cannabis Misuse
A study testing CUD-AMT and SUD-CBT in people with Cannabis Use Disorder, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Emerging evidence suggests that it is not the negative affect per se but underlying maladaptive cognitive, behavioral, and emotional responses to it that put an individual at risk of pathological substance use. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- CUD-AMT and SUD-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2018to 30 Jun 2021
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- must be between ages of 18-25; meet diagnostic criteria for cannabis use disorder; score > 1 Standard deviation above the norm on the Positive and Negative Affect Scale-Negative Affect Subscale, and > 1 standard deviation above the norm on either the Anxiety Sensitivity Index, the Distress Tolerance Scale, or the Emotion Regulation Questionnaire; either not on medication or stabilized on medication; fluent in English; and must satisfy usual fMRI criteria.
Who cannot join
- marked cognitive impairment; moderate to severe suicidality; unstable manic or psychotic symptoms; or primary substance of dependence is not cannabis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Matrix Institute on Addictions
Los Angeles, California, 90025
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Los Angeles, California, 90025
About this study
Official title: Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users
Emerging evidence suggests that it is not the negative affect per se but underlying maladaptive cognitive, behavioral, and emotional responses to it that put an individual at risk of pathological substance use. Maladaptive reactivity to negative affect may account for the association between substance-use and emotional disorders and may contribute to poor treatment outcomes for Substance Use Disorder. Thus, teaching adolescents and young adults (herein referred to as "adolescents") skills to manage negative affect may improve therapeutic outcomes of treatment for substance use disorder. Cannabis-use disorder (CUD) among adolescents is a prevalent and growing public health concern. Maladaptive reactivity to negative affect contributes to the maintenance of CUD and accounts for the associations between symptoms of emotional disorders and cannabis use. Still, maladaptive reactivity to negative affect has not yet been targeted in an intervention for CUD. Thus, the overarching aim of this proposal is to develop and pilot test a treatment for CUD that emphasizes the reduction of maladaptive responding to negative affect in adolescents. Participants will be placed in either a standard cognitive behavioral therapy for CUD, or the proposed affective management therapy. The investigators hypothesize that affective management training will yield greater reductions in the participants' use of cannabis, as well as greater improvements to the participants' negative thoughts and emotions, compared to the standard cognitive behavioral therapy.
Read the detailed description
This project aims to develop and evaluate a behavioral intervention for adolescent cannabis use disorder that emphasizes adaptive responding to negative affective symptoms (e.g., depression, anxiety). Maladaptive cognitive, behavioral, and emotional reactions to negative affect are associated with substance use and substance use problems (including cannabis). Adolescence and young adulthood represents a developmental period in which the regulation of negative emotions is still being developed, as well as a time when cannabis use is prevalent and cannabis use disorders onset. Thus, developing and evaluating cannabis use disorder interventions that emphasize the improvement of responding to negative affect may be particularly important for this developmental period. First, the investigators developed an intervention that weaves skills and strategies for responding adaptively to negative affect, particularly as it relates to high-risk times for cannabis craving and use, into an evidence-based substance use disorder intervention for individuals in late adolescence and early adulthood. After delivering it to a small sample of participants, the investigators will gather feedback to guide refinements to the intervention. After refining the intervention, which will be a 12-session individual treatment, we will conduct the pilot randomized clinical trial. Participants (N = 80) aged 18-25 with cannabis use disorder and elevations in constructs representing maladaptive reactivity to negative affect (i.e., high anxiety sensitivity, low distress tolerance, or facets of emotion dysregulation including high emotional suppression and low cognitive reappraisal ability) will be randomized to receive either: (a) standard cognitive behavioral therapy for adolescent substance use disorders (SUD-CBT) or (b) the novel intervention we develop, affective management training for cannabis use disorders (CUD-AMT). Participants will be assessed at baseline, post-treatment, and a 6-month follow-up assessment on self-report and behavioral indices of the targeted mechanisms, as well as on substance use outcomes (both cannabis-specific and substances more broadly defined). A sub-set of participants (n = 50) will also undergo pre- and post-treatment fMRI assessment to evaluate whether neural indices of emotion regulation are improved to a greater extent in CUD-AMT compared to SUD-CBT. Cannabis use disorder is the most prevalent substance use disorder among adolescents and young adults, and often leads to the use of other substances. Negative affect and disorders associated with high negative affect (i.e., anxiety and unipolar mood disorders) are highly prevalent and associated with significant substance use disorder comorbidity. Targeting a process that is still malleable in late adolescence and young adulthood and that is associated with the maintenance of substance use disorders has the potential to reduce the burden of substance use disorders in this population, thus making a significant public health impact.
- Conditions
- Cannabis Use Disorder
- Being tested
- CUD-AMT, SUD-CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUD-AMTBehavioural
Also called Cannabis Use Disorder-Affective Management Treatment
Participants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse
SUD-CBTBehavioural
Also called Substance Use Disorder-Cognitive Behavioral Therapy
Participants will receive traditional cognitive behavioral therapy for substance use disorder
| Study group | Role | What they receive |
|---|---|---|
| SUD-CBT | Active comparator | Standard cognitive behavioral therapy for substance use disorder Receives: Behavioral: SUD-CBT |
| CUD-AMT | Experimental | Experimental affective management training for cannabis use disorder specifically Receives: Behavioral: CUD-AMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline THC consumption at 3 months and 6 months
Urinalysis Toxicology Test primarily assessing levels of THC
Measured: baseline, 3 months, and 6 month follow-up
Secondary outcomes (3)
Change from baseline in number of cannabis use days at 3 months and 6 months
Timeline Followback assesses number of substance use days. At the time of each assessment, the period of time examined is the "past 30 days
Measured: baseline, 3 months, and 6 month follow-up
Change from baseline additional substance consumption at 3 months and 6 months
Urinalysis Toxicology Test used to test for additional substances other than THC
Measured: baseline, 3 months, and 6 month follow-up
Change in baseline cannabis abuse at 3 months and 6 months
Cannabis Abuse Screening Test assess cannabis-related problems by self-report
Measured: Baseline, 3 months, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start15 Feb 2018
- Primary completion15 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kate Taylor, University of California, Los Angeles
- Investigators
- Kate Wolitzky-Taylor, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432013
- Sponsor's protocol ID
- 1R34DA044350
- Status last verified
- May 2022
- First submitted
- 30 Jan 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users
- ClinicalTrials.gov ID
- NCT03432013
- Acronym / sponsor ID
- 1R34DA044350
- Conditions
- Cannabis Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Feb 2018 (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.
Emerging evidence suggests that it is not the negative affect per se but underlying maladaptive cognitive, behavioral, and emotional responses to it that put an individual at risk of pathological substance use. Maladaptive reactivity to negative affect may account for the association between substance-use and emotional disorders and may contribute to poor treatment outcomes for Substance Use Disorder. Thus, teaching adolescents and young adults (herein referred to as "adolescents") skills to manage negative affect may improve therapeutic outcomes of treatment for substance use disorder. Cannabis-use disorder (CUD) among adolescents is a prevalent and growing public health concern. Maladaptive reactivity to negative affect contributes to the maintenance of CUD and accounts for the associations between symptoms of emotional disorders and cannabis use. Still, maladaptive reactivity to negative affect has not yet been targeted in an intervention for CUD. Thus, the overarching aim of this proposal is to develop and pilot test a treatment for CUD that emphasizes the reduction of maladaptive responding to negative affect in adolescents. Participants will be placed in either a standard cognitive behavioral therapy for CUD, or the proposed affective management therapy. The investigators hypothesize that affective management training will yield greater reductions in the participants' use of cannabis, as well as greater improvements to the participants' negative thoughts and emotions, compared to the standard cognitive behavioral therapy.
Detailed description
This project aims to develop and evaluate a behavioral intervention for adolescent cannabis use disorder that emphasizes adaptive responding to negative affective symptoms (e.g., depression, anxiety). Maladaptive cognitive, behavioral, and emotional reactions to negative affect are associated with substance use and substance use problems (including cannabis). Adolescence and young adulthood represents a developmental period in which the regulation of negative emotions is still being developed, as well as a time when cannabis use is prevalent and cannabis use disorders onset. Thus, developing and evaluating cannabis use disorder interventions that emphasize the improvement of responding to negative affect may be particularly important for this developmental period. First, the investigators developed an intervention that weaves skills and strategies for responding adaptively to negative affect, particularly as it relates to high-risk times for cannabis craving and use, into an evidence-based substance use disorder intervention for individuals in late adolescence and early adulthood. After delivering it to a small sample of participants, the investigators will gather feedback to guide refinements to the intervention. After refining the intervention, which will be a 12-session individual treatment, we will conduct the pilot randomized clinical trial. Participants (N = 80) aged 18-25 with cannabis use disorder and elevations in constructs representing maladaptive reactivity to negative affect (i.e., high anxiety sensitivity, low distress tolerance, or facets of emotion dysregulation including high emotional suppression and low cognitive reappraisal ability) will be randomized to receive either: (a) standard cognitive behavioral therapy for adolescent substance use disorders (SUD-CBT) or (b) the novel intervention we develop, affective management training for cannabis use disorders (CUD-AMT). Participants will be assessed at baseline, post-treatment, and a 6-month follow-up assessment on self-report and behavioral indices of the targeted mechanisms, as well as on substance use outcomes (both cannabis-specific and substances more broadly defined). A sub-set of participants (n = 50) will also undergo pre- and post-treatment fMRI assessment to evaluate whether neural indices of emotion regulation are improved to a greater extent in CUD-AMT compared to SUD-CBT. Cannabis use disorder is the most prevalent substance use disorder among adolescents and young adults, and often leads to the use of other substances. Negative affect and disorders associated with high negative affect (i.e., anxiety and unipolar mood disorders) are highly prevalent and associated with significant substance use disorder comorbidity. Targeting a process that is still malleable in late adolescence and young adulthood and that is associated with the maintenance of substance use disorders has the potential to reduce the burden of substance use disorders in this population, thus making a significant public health impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUD-CBT | Active comparator | Behavioral: SUD-CBTStandard cognitive behavioral therapy for substance use disorder |
| CUD-AMT | Experimental | Behavioral: CUD-AMTExperimental affective management training for cannabis use disorder specifically |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- must be between ages of 18-25; meet diagnostic criteria for cannabis use disorder; score > 1 Standard deviation above the norm on the Positive and Negative Affect Scale-Negative Affect Subscale, and > 1 standard deviation above the norm on either the Anxiety Sensitivity Index, the Distress Tolerance Scale, or the Emotion Regulation Questionnaire; either not on medication or stabilized on medication; fluent in English; and must satisfy usual fMRI criteria.
Key exclusion criteria (1 listed)
- marked cognitive impairment; moderate to severe suicidality; unstable manic or psychotic symptoms; or primary substance of dependence is not cannabis.
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 |
|---|---|---|
| CUD-AMTAlso: Cannabis Use Disorder-Affective Management TreatmentParticipants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse | Behavioural | CUD-AMT |
| SUD-CBTAlso: Substance Use Disorder-Cognitive Behavioral TherapyParticipants will receive traditional cognitive behavioral therapy for substance use disorder | Behavioural | SUD-CBT |
Primary outcome
Change from baseline THC consumption at 3 months and 6 months
Time frame: baseline, 3 months, and 6 month follow-up
Urinalysis Toxicology Test primarily assessing levels of THC
3 secondary outcomes
Change from baseline in number of cannabis use days at 3 months and 6 months
Time frame: baseline, 3 months, and 6 month follow-up
Change from baseline additional substance consumption at 3 months and 6 months
Time frame: baseline, 3 months, and 6 month follow-up
Change in baseline cannabis abuse at 3 months and 6 months
Time frame: Baseline, 3 months, and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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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.
Kate Wolitzky-Taylor, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CUD-AMT and SUD-CBT in people with Cannabis Use Disorder, run by University of California, Los Angeles at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline THC consumption at 3 months and 6 months (time frame: baseline, 3 months, and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.