CannabisiCURENCT05401929
Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
A study testing iTBS in people with Cannabis, run by Duke University at 1 site in United States.
Trial summary
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males/non-pregnant females, 18-65 years old
- Current cannabis user
- Able to perform all study procedures
Who cannot join
- Regular use of other illicit drugs
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Tonisha Kearney-Ramos, PhD, 919-613-8153, tonisha.kearney-ramos@duke.edu
About this study
Official title: Imaging the Effects of Intermittent Thetaburst Stimulation on Cannabis Self-Administration in Heavy Cannabis Users
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use.
In this study, fifty (50) treatment-seeking, near-daily cannabis users will be recruited to receive either active or sham (placebo) repetitive TMS (rTMS). Participants will complete a total of 25 treatment sessions, delivered as five sessions per day across five days, with sessions flexibly scheduled over a two-week period. Measures of cannabis use and brain activity will be collected before and after treatment using real-time self-report assessments and functional magnetic resonance imaging (fMRI), respectively. Specifically, cannabis use will be assessed in participants' everyday environments using brief text-message surveys during a two-week baseline period, the two-week treatment period, and a four-week follow-up period.
The study aims to determine whether active rTMS reduces brain activity in response to cannabis cues, decreases automatic attention to cannabis cues, and leads to meaningful reductions in cannabis use compared to sham treatment.
Read the detailed description
The expanding legalization of cannabis across the U.S. is associated with increases in cannabis use and, accordingly, an increase in the number of individuals with cannabis use disorder (CUD). One key predictor of relapse is elevated attentional bias to drug cues, coupled with attenuated cognitive control in the presence of those cues. Attentional bias to drug cues is associated with increased activity in the Salience Network (SN), including the anterior cingulate cortex and bilateral anterior insula, as well as reduced activity in the dorsolateral prefrontal cortex (DLPFC) and broader cognitive control circuitry during exposure to cannabis cues.
Our prior data demonstrate that neural responses to drug cues can be reduced by attenuating ventromedial prefrontal cortex (VMPFC) and reward circuitry using inhibitory repetitive transcranial magnetic stimulation (rTMS) (Strategy 1). An alternative approach, however, may be to enhance activity in the DLPFC and cognitive control circuitry, which may also reduce neural reactivity to drug cues by inversely regulating SN cue hyper-reactivity (Strategy 2, the focus of this K01). Through the research and training plan outlined in this K01 proposal, I seek to evaluate the ability of left DLPFC-targeted rTMS to attenuate SN drug cue reactivity and attentional bias, and to reduce cannabis use. This will be accomplished by applying accelerated intermittent theta burst stimulation (aiTBS), a novel patterned excitatory form of rTMS, to the L DLPFC in heavy cannabis users.
GOAL. The primary objectives of this K01 research project are to:
- determine whether L DLPFC aiTBS decreases cannabis use using real-time data collected in the natural environment;
- determine whether aiTBS-induced changes in cannabis use are associated with changes in Salience Network drug cue reactivity; and
- assess whether L DLPFC aiTBS is feasible, tolerable, and safe relative to sham stimulation.
DESIGN. Fifty (50) treatment-seeking, heavy (near-daily) cannabis users will be randomized to receive either active or sham aiTBS targeting the L DLPFC. Participants will complete a total of 25 treatment sessions, delivered as five sessions per day (50-min inter-session interval) across five treatment days, with visits flexibly scheduled over a two-week period. Cannabis use data will be collected throughout the study, and functional magnetic resonance imaging (fMRI) data will be collected before and after aiTBS treatment, as well as following a 4-week follow-up period.
Cannabis use in the natural environment will be assessed using Ecological Momentary Assessment (EMA) during a two-week baseline (pre-treatment) period, a two-week treatment period, and a four-week follow-up period. Frequency of use (days per week) and quantity of use (average grams per use day) will be captured via EMA and corroborated during the four follow-up visits using Timeline Followback (TLFB) interviews and urine toxicology to assess cannabis and other substance use and to monitor for adverse events.
We will test the hypotheses that active aiTBS will reduce neural reactivity to cannabis cues (Aim 2), reduce cannabis use frequency and/or quantity (Aim 1), and demonstrate non-inferior feasibility, tolerability, and safety compared to sham stimulation (Safety Aim).
Over the two-year recruitment period, this project will generate a critical dataset to advance brain stimulation treatment development for CUD. In addition, these data will support a subsequent R01 application aimed at extending this line of treatment development research. Finally, this project will provide essential training in human behavioral pharmacology and clinical trial research design and analysis, supporting my progression toward independence as an interdisciplinary addiction neuroscientist.
- Conditions
- Cannabis
- Being tested
- iTBS
- Keywords
- cannabis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, intermittent theta burst stimulation, functional magnetic resonance imaging, functional neuroimaging, functional brain imaging, marijuana, cannabis smoking, marijuana smoking, recreational marijuana use, stroop task, attentional bias, drug cue reactivity, intervention, treatment, double blind, sham, sham controlled, ecological momentary assessment
- Medical subject headings
- Marijuana Abuse, Marijuana Smoking, Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Also called Repetitive transcranial magnetic stimulation, Patterned repetitive transcranial magnetic stimulation, rTMS, intermittent thetaburst stimulation
Sixty trains of active intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec [30 pulses/train]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.
iTBSDevice
Sixty trains of sham intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec [30 pulses/train]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Device: iTBS |
| Sham | Sham comparator | Not described Receives: Device: iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cannabis use
On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use frequency will be measured as the number of days per week they report cannabis use. During the two-week pre-treatment period, we will calculate the baseline frequency as the average number of use days per week across those two weeks. Cannabis use frequency will then be assessed during each of the two treatment weeks (Week 0-1) and during the four-week follow-up period (Weeks 2-5), and the follow-up period will subsequently be compared relative to baseline. This is corroborated by TLFB.
Measured: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)
Quantity of cannabis use
On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use quantity will be measured as the average number of grams used per use-day during each week in which they report cannabis use. During the two-week pre-treatment/baseline period (Days 1-14), we will calculate the baseline quantity as the average daily grams used per use-day across those two weeks. Cannabis use quantity will then be assessed during the treatment phase (Days 15-28) and during the 4-week follow-up period (Days 29-56), and the follow-up period will subsequently be compared relative to baseline. This will be corroborated by TLFB.
Measured: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)
Secondary outcomes (4)
Salience Network drug cue reactivity
Brain activity in response to cannabis-related versus neutral cues will be assessed using the Cannabis Stroop fMRI task, in which visual stimuli are presented and the Salience Network (SN) typically shows greater activation to drug cues than to neutral cues. This pattern reflects heightened SN drug-cue reactivity, or an attentional bias toward drug-related information. First, a data-driven approach called independent component analysis (ICA) will be used to identify and extract the SN timecourse and spatial map from the Stroop fMRI task data. Second, a general linear model (GLM) analysis will be used to relate each participant's SN timecourse to the task design (timing model of cue presentation blocks), allowing us to quantify SN activity during cannabis versus neutral cue task conditions. The primary outcome will be each participant's SN contrast beta value, a statistic derived from the ICA-GLM analysis that reflects the magnitude and direction of SN drug cue reactivity.
Measured: Pre-treatment/Baseline (Day 14), Immediate Post-treatment (Day 28), 4-Week Post-treatment Follow-up (Day 56)
Feasibility (attendance)
Feasibility will be measured as the percentage of scheduled TMS sessions completed by participants in each treatment group. For participants randomized to a TMS treatment group (active vs. sham) who attend at least one TMS session, we will quantify the total number of sessions completed. Feasibility will then be calculated as the percentage of planned TMS sessions that were successfully completed by each participant.
Measured: Two-week Treatment phase (Days 15-28)
Tolerability (withdrawals)
Tolerability will be measured as the proportion of participants who withdraw from the study before completing all planned TMS sessions. Among participants randomized to a TMS treatment group (active vs. sham) who attend at least one TMS session, we will identify those who discontinue prior to completing their final scheduled TMS session. Tolerability will then be quantified as the percentage of participants who withdraw before completing the full course of planned TMS treatments.
Measured: Two-week Treatment phase (Days 15-28)
Safety (AEs)
Safety will be measured as the frequency, type, and severity of treatment-related adverse events (AEs) reported during and after the TMS treatment period, categorized according to standard AE reporting guidelines. Among participants randomized to a TMS treatment group (active vs. sham) who attend at least one TMS session and receive any amount of TMS, we will quantify the number, type, and severity of subsequent treatment-related AEs. Adverse event profiles will then be compared between the active and sham treatment groups.
Measured: Two-week Treatment phase (Days 15-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jun 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tonisha Kearney-Ramos, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401929
- Sponsor's protocol ID
- Pro00118090
- Other IDs
- K01DA050691
- Acronym
- iCURE
- Status last verified
- Jan 2026
- First submitted
- 27 May 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Effects of Intermittent Thetaburst Stimulation on Cannabis Self-Administration in Heavy Cannabis Users
- ClinicalTrials.gov ID
- NCT05401929
- Acronym / sponsor ID
- iCURE / Pro00118090
- Conditions
- Cannabis
- Keywords
- cannabis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, intermittent theta burst stimulation, functional magnetic resonance imaging, functional neuroimaging, functional brain imaging, marijuana
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 2 Jun 2022 (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.
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use.
In this study, fifty (50) treatment-seeking, near-daily cannabis users will be recruited to receive either active or sham (placebo) repetitive TMS (rTMS). Participants will complete a total of 25 treatment sessions, delivered as five sessions per day across five days, with sessions flexibly scheduled over a two-week period. Measures of cannabis use and brain activity will be collected before and after treatment using real-time self-report assessments and functional magnetic resonance imaging (fMRI), respectively. Specifically, cannabis use will be assessed in participants' everyday environments using brief text-message surveys during a two-week baseline period, the two-week treatment period, and a four-week follow-up period.
The study aims to determine whether active rTMS reduces brain activity in response to cannabis cues, decreases automatic attention to cannabis cues, and leads to meaningful reductions in cannabis use compared to sham treatment.
Detailed description
The expanding legalization of cannabis across the U.S. is associated with increases in cannabis use and, accordingly, an increase in the number of individuals with cannabis use disorder (CUD). One key predictor of relapse is elevated attentional bias to drug cues, coupled with attenuated cognitive control in the presence of those cues. Attentional bias to drug cues is associated with increased activity in the Salience Network (SN), including the anterior cingulate cortex and bilateral anterior insula, as well as reduced activity in the dorsolateral prefrontal cortex (DLPFC) and broader cognitive control circuitry during exposure to cannabis cues.
Our prior data demonstrate that neural responses to drug cues can be reduced by attenuating ventromedial prefrontal cortex (VMPFC) and reward circuitry using inhibitory repetitive transcranial magnetic stimulation (rTMS) (Strategy 1). An alternative approach, however, may be to enhance activity in the DLPFC and cognitive control circuitry, which may also reduce neural reactivity to drug cues by inversely regulating SN cue hyper-reactivity (Strategy 2, the focus of this K01). Through the research and training plan outlined in this K01 proposal, I seek to evaluate the ability of left DLPFC-targeted rTMS to attenuate SN drug cue reactivity and attentional bias, and to reduce cannabis use. This will be accomplished by applying accelerated intermittent theta burst stimulation (aiTBS), a novel patterned excitatory form of rTMS, to the L DLPFC in heavy cannabis users.
GOAL. The primary objectives of this K01 research project are to:
- determine whether L DLPFC aiTBS decreases cannabis use using real-time data collected in the natural environment;
- determine whether aiTBS-induced changes in cannabis use are associated with changes in Salience Network drug cue reactivity; and
- assess whether L DLPFC aiTBS is feasible, tolerable, and safe relative to sham stimulation.
DESIGN. Fifty (50) treatment-seeking, heavy (near-daily) cannabis users will be randomized to receive either active or sham aiTBS targeting the L DLPFC. Participants will complete a total of 25 treatment sessions, delivered as five sessions per day (50-min inter-session interval) across five treatment days, with visits flexibly scheduled over a two-week period. Cannabis use data will be collected throughout the study, and functional magnetic resonance imaging (fMRI) data will be collected before and after aiTBS treatment, as well as following a 4-week follow-up period.
Cannabis use in the natural environment will be assessed using Ecological Momentary Assessment (EMA) during a two-week baseline (pre-treatment) period, a two-week treatment period, and a four-week follow-up period. Frequency of use (days per week) and quantity of use (average grams per use day) will be captured via EMA and corroborated during the four follow-up visits using Timeline Followback (TLFB) interviews and urine toxicology to assess cannabis and other substance use and to monitor for adverse events.
We will test the hypotheses that active aiTBS will reduce neural reactivity to cannabis cues (Aim 2), reduce cannabis use frequency and/or quantity (Aim 1), and demonstrate non-inferior feasibility, tolerability, and safety compared to sham stimulation (Safety Aim).
Over the two-year recruitment period, this project will generate a critical dataset to advance brain stimulation treatment development for CUD. In addition, these data will support a subsequent R01 application aimed at extending this line of treatment development research. Finally, this project will provide essential training in human behavioral pharmacology and clinical trial research design and analysis, supporting my progression toward independence as an interdisciplinary addiction neuroscientist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: iTBS |
| Sham | Sham comparator | Device: iTBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males/non-pregnant females, 18-65 years old
- Current cannabis user
- Able to perform all study procedures
Key exclusion criteria (2 listed)
- Regular use of other illicit drugs
- If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
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 |
|---|---|---|
| iTBSAlso: Repetitive transcranial magnetic stimulation, Patterned repetitive transcranial magnetic stimulation, rTMS, intermittent thetaburst stimulationSixty trains of active intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec [30 pulses/train]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils. | Device | Active |
| iTBSSixty trains of sham intermittent thetaburst stimulation (iTBS) (1 train = 10 sec of 2 sec ON, 8 sec OFF; 3-pulse bursts at 5 Hz; 15 pulses/sec [30 pulses/train]; 60 trains/session; 1,800 pulses/session) using neuronavigation-guided cortical targeting to the left dorsolateral prefrontal cortex location using figure-of-8 TMS coils. | Device | Sham |
Primary outcome
Frequency of cannabis use
Time frame: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)
On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use frequency will be measured as the number of days per week they report cannabis use. During the two-week pre-treatment period, we will calculate the baseline frequency as the average number of use days per week across those two weeks. Cannabis use frequency will then be assessed during each of the two treatment weeks (Week 0-1) and during the four-week follow-up period (Weeks 2-5), and the follow-up period will subsequently be compared relative to baseline. This is corroborated by TLFB.
Quantity of cannabis use
Time frame: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)
On each study day, participants will receive EMA text surveys on their cellphones. For each participant, cannabis use quantity will be measured as the average number of grams used per use-day during each week in which they report cannabis use. During the two-week pre-treatment/baseline period (Days 1-14), we will calculate the baseline quantity as the average daily grams used per use-day across those two weeks. Cannabis use quantity will then be assessed during the treatment phase (Days 15-28) and during the 4-week follow-up period (Days 29-56), and the follow-up period will subsequently be compared relative to baseline. This will be corroborated by TLFB.
4 secondary outcomes
Salience Network drug cue reactivity
Time frame: Pre-treatment/Baseline (Day 14), Immediate Post-treatment (Day 28), 4-Week Post-treatment Follow-up (Day 56)
Feasibility (attendance)
Time frame: Two-week Treatment phase (Days 15-28)
Tolerability (withdrawals)
Time frame: Two-week Treatment phase (Days 15-28)
Safety (AEs)
Time frame: Two-week Treatment phase (Days 15-28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tonisha Kearney-Ramos, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS in people with Cannabis, run by Duke University 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 3 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tonisha Kearney-Ramos, PhD (919-613-8153, tonisha.kearney-ramos@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of cannabis use (time frame: Two-week Pre-treatment/Baseline phase (Days 1-14), Two-week Treatment phase (Days 15-28), Four-week Post-treatment phase (Days 29-56)). 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?
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 13 Jul 2026.