Cannabis DependencePhase 1NCT01875796
Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
A Phase 1 study testing Cognitive-Behavioral Therapy, Motivation Enhancement Therapy and Integrated Cannabis and Anxiety Reduction Treatment in people with Cannabis Dependence and Anxiety Disorders, run by Louisiana State University and A&M College at 1 site in United States.
Trial summary
This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Dependence, Anxiety Disorders, Cannabis Use Disorder
- What is being tested?
- Cognitive-Behavioral Therapy, Motivation Enhancement Therapy and Integrated Cannabis and Anxiety Reduction Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2016
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cannabis use disorder
- An additional diagnosis of an anxiety disorder
- Patient reports that at least some of his/her cannabis use is aimed at reducing anxiety and/or for social facilitation.
- Patient reports that cannabis is his/her substance of choice for anxiety management.
- Concurrent use of psychotropic medications (e.g., selective serotonin reuptake inhibitors) is permitted as long as patients have been on a stable dose for at least three months prior to entering the study and they are willing to remain stable on their medication for the duration of treatment.
- Age between 18 and 65 years.
- English language fluency.
- Willing and able to provide written informed consent.
Who cannot join
- Alcohol or illicit substance (non-cannabis) dependence.
- Cannabis use behavior sufficiently uncontrolled that proper participation in study protocol would likely be disrupted.
- History of schizophrenia, bipolar disorder, or organic brain syndrome.
- Prominent suicidal ideation with intent that is judged to be clinically significant.
- Mental retardation or another pervasive developmental disability (e.g., Asperger's Disorder).
- Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless).
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- Prior simultaneous cognitive behavioral treatment for cannabis dependence and anxiety disorders.
- Legally mandated to receive substance abuse treatment.
- Report of current participation in or intent to participate in an additional (i.e., treatments other than MET-CBT or MET alone) anxiety or substance abuse treatment method during the course of the study.
- Unwilling to maintain stable dose of regularly-dosed medications during the study
- Unwilling to cease PRN (pro re nata or "as needed") use of benzodiazepines or other fast-acting anxiolytics prior to entrance into social situations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Anxiety & Addictive Behaviors Clinic
Baton Rouge, Louisiana, 70803
About this study
This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders.
Read the detailed description
Cannabis use disorder (CUD) is the most common illicit substance dependence and people with CUD are highly vulnerable to anxiety disorders. The co-occurrence of anxiety disorders among those with CUD is a pressing public health matter given elevated anxiety is related to poorer cannabis treatment outcomes. Cannabis-related problems among those with anxiety disorders may be maintained by a reliance on cannabis to manage anxiety. Investigations of the treatment of these conditions when they co-occur have been virtually absent. Motivation enhancement therapy (MET) combined with cognitive-behavioral therapy (CBT) is an efficacious intervention for cannabis CUD, yet outcomes are highly limited for anxious patients. Transdiagnostic anxiety treatments can facilitate the treatment of patients with anxiety psychopathology regardless of the specific type of anxiety disorder. One such treatment, False Safety Behavior Elimination Treatment (FSET), may be particularly useful with anxious patients with CUD as it focuses on the elimination of behaviors that may be effective in decreasing anxiety in the short-term, but can maintain and even exacerbate anxiety in the long-term (i.e., false safety behaviors). The use of cannabis to manage anxiety can, therefore, be targeted in such a treatment. This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with CUD and anxiety disorders. Phase I of the project includes development and refinement of a specialized group protocol (i.e., Integrated Cannabis and Anxiety Reduction Treatment or ICART) for integrating MET-CBT for CUD with FSET. The initial protocol will be modified based on the experience gained during group treatment with the integrated treatment. Phase II will be a randomized controlled trial examining the relative efficacy of the refined ICART treatment versus MET-CBT alone. After post-treatment assessments, the ICART group will be followed for 3 months to examine maintenance of gains; the participants originally assigned to the control condition will be offered ICART. It is hypothesized that ICART will produce better outcomes than the control.
- Being tested
- Cognitive-Behavioral Therapy, Motivation Enhancement Therapy, Integrated Cannabis and Anxiety Reduction Treatment, False Safety Behavior Elimination Therapy
- Keywords
- cannabis, marijuana, anxiety, transdiagnostic, dual diagnosis, cannabis abuse, cannabis dependence, cannabis use disorder
- Medical subject headings
- Marijuana Abuse, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
Motivation Enhancement TherapyBehavioural
Integrated Cannabis and Anxiety Reduction TreatmentBehavioural
False Safety Behavior Elimination TherapyBehavioural
Also called Transdiagnostic anxiety disorder treatment
| Study group | Role | What they receive |
|---|---|---|
| Cannabis & Anxiety Reduction Treatment | Experimental | Cognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use. Receives: Behavioral: Cognitive-Behavioral Therapy; Behavioral: Motivation Enhancement Therapy; Behavioral: Integrated Cannabis and Anxiety Reduction Treatment; Behavioral: False Safety Behavior Elimination Therapy |
| Motivation/cognitive-behavioral therapy | Active comparator | Motivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use. Receives: Behavioral: Cognitive-Behavioral Therapy; Behavioral: Motivation Enhancement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cannabis use
Measured: change from baseline to weeks 6, 12, & 32
cannabis-related problems
Measured: change from baseline to weeks 6, 12, & 32
Secondary outcomes (1)
anxiety
Measured: change from baseline to weeks 6, 12, & 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis DependenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Julia Buckner, Louisiana State University and A&M College
- Investigators
- Julia D Buckner, PhD, Principal investigator, Louisiana State University Health Sciences Center in New OrleansMichael J Zvolensky, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875796
- Sponsor's protocol ID
- RDA031937A
- Other IDs
- 1R34DA031937-01
- Status last verified
- Aug 2016
- First submitted
- 10 Jun 2013
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buckner JD, Morris PE, Zvolensky MJ. Integrated cognitive-behavioral therapy for comorbid cannabis use and anxiety disorders: The impact of severity of cannabis use. Exp Clin Psychopharmacol. 2021 Jun;29(3):272-278. doi: 10.1037/pha0000456. Epub 2021 Apr 22.
PubMed 34264732
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
- ClinicalTrials.gov ID
- NCT01875796
- Acronym / sponsor ID
- RDA031937A
- Keywords
- cannabis, marijuana, anxiety, transdiagnostic, dual diagnosis, cannabis abuse, cannabis dependence, cannabis use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013
- Primary completion
- Jul 2016 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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.
This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders.
Detailed description
Cannabis use disorder (CUD) is the most common illicit substance dependence and people with CUD are highly vulnerable to anxiety disorders. The co-occurrence of anxiety disorders among those with CUD is a pressing public health matter given elevated anxiety is related to poorer cannabis treatment outcomes. Cannabis-related problems among those with anxiety disorders may be maintained by a reliance on cannabis to manage anxiety. Investigations of the treatment of these conditions when they co-occur have been virtually absent. Motivation enhancement therapy (MET) combined with cognitive-behavioral therapy (CBT) is an efficacious intervention for cannabis CUD, yet outcomes are highly limited for anxious patients. Transdiagnostic anxiety treatments can facilitate the treatment of patients with anxiety psychopathology regardless of the specific type of anxiety disorder. One such treatment, False Safety Behavior Elimination Treatment (FSET), may be particularly useful with anxious patients with CUD as it focuses on the elimination of behaviors that may be effective in decreasing anxiety in the short-term, but can maintain and even exacerbate anxiety in the long-term (i.e., false safety behaviors). The use of cannabis to manage anxiety can, therefore, be targeted in such a treatment. This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with CUD and anxiety disorders. Phase I of the project includes development and refinement of a specialized group protocol (i.e., Integrated Cannabis and Anxiety Reduction Treatment or ICART) for integrating MET-CBT for CUD with FSET. The initial protocol will be modified based on the experience gained during group treatment with the integrated treatment. Phase II will be a randomized controlled trial examining the relative efficacy of the refined ICART treatment versus MET-CBT alone. After post-treatment assessments, the ICART group will be followed for 3 months to examine maintenance of gains; the participants originally assigned to the control condition will be offered ICART. It is hypothesized that ICART will produce better outcomes than the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis & Anxiety Reduction Treatment | Experimental | Behavioral: Cognitive-Behavioral Therapy, Behavioral: Motivation Enhancement Therapy, Behavioral: Integrated Cannabis and Anxiety Reduction Treatment, Behavioral: False Safety Behavior Elimination TherapyCognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use. |
| Motivation/cognitive-behavioral therapy | Active comparator | Behavioral: Cognitive-Behavioral Therapy, Behavioral: Motivation Enhancement TherapyMotivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cannabis use disorder
- An additional diagnosis of an anxiety disorder
- Patient reports that at least some of his/her cannabis use is aimed at reducing anxiety and/or for social facilitation.
- Patient reports that cannabis is his/her substance of choice for anxiety management.
- Concurrent use of psychotropic medications (e.g., selective serotonin reuptake inhibitors) is permitted as long as patients have been on a stable dose for at least three months prior to entering the study and they are willing to remain stable on their medication for the duration of treatment.
Key exclusion criteria (11 listed)
- Alcohol or illicit substance (non-cannabis) dependence.
- Cannabis use behavior sufficiently uncontrolled that proper participation in study protocol would likely be disrupted.
- History of schizophrenia, bipolar disorder, or organic brain syndrome.
- Prominent suicidal ideation with intent that is judged to be clinically significant.
- Mental retardation or another pervasive developmental disability (e.g., Asperger's 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 |
|---|---|---|
| Cognitive-Behavioral Therapy | Behavioural | Cannabis & Anxiety Reduction Treatment, Motivation/cognitive-behavioral therapy |
| Motivation Enhancement Therapy | Behavioural | Cannabis & Anxiety Reduction Treatment, Motivation/cognitive-behavioral therapy |
| Integrated Cannabis and Anxiety Reduction Treatment | Behavioural | Cannabis & Anxiety Reduction Treatment |
| False Safety Behavior Elimination TherapyAlso: Transdiagnostic anxiety disorder treatment | Behavioural | Cannabis & Anxiety Reduction Treatment |
Primary outcome
cannabis use
Time frame: change from baseline to weeks 6, 12, & 32
cannabis-related problems
Time frame: change from baseline to weeks 6, 12, & 32
1 secondary outcome
anxiety
Time frame: change from baseline to weeks 6, 12, & 32
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 25 Aug 2016.
- Derived from this study: PubMed 34264732Buckner JD, Morris PE, Zvolensky MJ. Integrated cognitive-behavioral therapy for comorbid cannabis use and anxiety disorders: The impact of severity of cannabis use. Exp Clin Psychopharmacol. 2021 Jun;29(3):272-278. doi: 10.1037/pha0000456. Epub 2021 Apr 22.
- online screeningLink provided by the sponsor.
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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.
Julia D Buckner, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
Michael J Zvolensky, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive-Behavioral Therapy, Motivation Enhancement Therapy and Integrated Cannabis and Anxiety Reduction Treatment in people with Cannabis Dependence and Anxiety Disorders, run by Louisiana State University and A&M College 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 8 inclusion and 11 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 25 Aug 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cannabis use (time frame: change from baseline to weeks 6, 12, & 32). The study lists 2 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 NCT01875796, which also lists 1 linked publication.
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 25 Aug 2016.