Cannabis Use Disorder, SevereICAENCT07746440
Impact of Cannabis Use and Abstinence on Emotion
A study testing Contingency management for cannabis abstinence and lab visit attendance and Contingency management for lab visit attendance in people with Cannabis Use Disorder, Severe, run by Florida State University at 1 site in United States.
Trial summary
The goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are: Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Cannabis Use Disorder, Severe
- What is being tested?
- Contingency management for cannabis abstinence and lab visit attendance and Contingency management for lab visit attendance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 15 Jul 2024
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- >=5 cannabis use days per week on average over the past 3 months
- Female
- >=6 past-year CUD symptoms (must include withdrawal and at least one criterion other than craving must be met within the past 3 months)
- >=20 days of cannabis use over the past 30 days
- Positive urinalysis for THC
- Cannabis is primary substance of abuse
Who cannot join
- Current pregnancy
- History of psychotic, seizure, or cardiovascular disorder
- Immediate plan to quit cannabis
- Current treatment for cannabis use
- Current daily psychotropic medication use
- Lotion allergy
Show all 10Show fewer
- Positive urinalysis for any drug other than THC
- CSRSS >= 4
- Current moderate (4+ criteria) or severe (6+ criteria) substance use disorder (SUD) other than CUD or nicotine dependence
- CBD use >= 9 days
Trial locations and contacts
1 site in 1 country.
United States1 site
The BRAINS Lab in the Department of Psychology at Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Impact of Cannabis Withdrawal and Early Abstinence on Threat and Reward Processing
The goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are:
Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence from cannabis?
Read more
Compared to using cannabis as usual, will threat reactivity be elevated at weeks 1 and 2 of abstinence followed by a decrease at week 3 of abstinence?
Compared to using cannabis as usual, will non-drug reward reactivity be lower at weeks 1 and 2 of abstinence followed by an increase at week 3 of abstinence?
Compared to successful 3-week abstainers, will threat, non-drug reward, and cannabis cue reactivity differ in relapsers?
Researchers will compare females with CUD who abstain from cannabis for three weeks to those who continue to use cannabis as usual to see how cannabis abstinence impacts threat and reward processing.
Participants will:
Be randomly assigned to continue using cannabis as usual or abstain from cannabis for three weeks Visit the lab 6 times over three weeks, followed by a 1-month follow-up lab visit for the participants assigned to the cannabis abstinence condition Complete phone surveys every other day across the three week study period
- Conditions
- Cannabis Use Disorder, Severe
- Being tested
- Contingency management for cannabis abstinence and lab visit attendance, Contingency management for lab visit attendance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency management for cannabis abstinence and lab visit attendanceBehavioural
Escalating monetary reinforcement is provided for continuous cannabis abstinence and lab visit attendance across the three week study period.
Contingency management for lab visit attendanceBehavioural
Escalating monetary reinforcement is provided for lab visit attendance across the three week study period.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management for Cannabis Abstinence and Lab Visit Attendance | Experimental | Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce sustained abstinence from cannabis and attendance at all lab visits. Receives: Behavioral: Contingency management for cannabis abstinence and lab visit attendance |
| Contingency Management for Lab Visit Attendance | Other | Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce attendance at all lab visits. Participants will continue to use cannabis as usual. Receives: Behavioral: Contingency management for lab visit attendance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Positive Potential
The Late Positive Potential (neural measure recorded via electroencephalography) will be quantified from ~400 to 3000ms at central-parietal sensors relative to the onset of a cannabis, neutral, unpleasant, or pleasant image. The Late Positive Potential to cannabis vs. neutral and cannabis vs. pleasant will be the primary contrasts of interest.
Measured: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
Reward Positivity
The Reward Positivity (neural measure recorded via electroencephalography) will be quantified from ~200-300ms at frontal-central sensors relative to the onset of monetary win and loss feedback. The win vs. loss contrast will be the primary outcome of interest.
Measured: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
Eyeblink Startle Response
The Eyeblink Startle Response (recorded via EMG sensors) will be quantified as the peak blink amplitude relative to the onset of an auditory startle probe during blocks with predictable shocks, unpredictable shocks, and no threat of shock. The Eyeblink Startle Response during unpredictable shock threat vs. no shock threat will be the primary contrast of interest.
Measured: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
Secondary outcomes (2)
Delta Power
Delta Power (neural time-frequency measure recorded via electroencephalography) will be quantified as event-related spectral power from 1-3.5Hz at frontal-central sensors relative to the onset of monetary win and loss feedback. The win vs. loss contrast will be the primary outcome of interest.
Measured: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
Delta Intertrial Phase Coherence
Delta Intertrial Phase Coherence (neural time-frequency measure recorded via electroencephalography) will be quantified as intertrial phase coherence of 1-3.5Hz oscillations at frontal-central sensors relative to the onset of monetary win and loss feedback. The win vs. loss contrast will be the primary outcome of interest.
Measured: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-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 posted5 Aug 2026
- Study start24 Jan 2022
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use Disorder, SevereStudies of the same condition, open and under way.
- More trials run by Florida State 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University
- Responsible party
- Principal investigator, Rick James Macatee, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746440
- Sponsor's protocol ID
- AUIRB#20-217FB
- Acronym
- ICAE
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cannabis Withdrawal and Early Abstinence on Threat and Reward Processing
- ClinicalTrials.gov ID
- NCT07746440
- Acronym / sponsor ID
- ICAE / AUIRB#20-217FB
- Conditions
- Cannabis Use Disorder, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Auburn University
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 5 Aug 2026 (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 goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are:
Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence from cannabis?
Compared to using cannabis as usual, will threat reactivity be elevated at weeks 1 and 2 of abstinence followed by a decrease at week 3 of abstinence?
Compared to using cannabis as usual, will non-drug reward reactivity be lower at weeks 1 and 2 of abstinence followed by an increase at week 3 of abstinence?
Compared to successful 3-week abstainers, will threat, non-drug reward, and cannabis cue reactivity differ in relapsers?
Researchers will compare females with CUD who abstain from cannabis for three weeks to those who continue to use cannabis as usual to see how cannabis abstinence impacts threat and reward processing.
Participants will:
Be randomly assigned to continue using cannabis as usual or abstain from cannabis for three weeks Visit the lab 6 times over three weeks, followed by a 1-month follow-up lab visit for the participants assigned to the cannabis abstinence condition Complete phone surveys every other day across the three week study period
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management for Cannabis Abstinence and Lab Visit Attendance | Experimental | Behavioral: Contingency management for cannabis abstinence and lab visit attendanceParticipants randomly assigned to this arm will receive contingency management for three weeks to reinforce sustained abstinence from cannabis and attendance at all lab visits. |
| Contingency Management for Lab Visit Attendance | Other | Behavioral: Contingency management for lab visit attendanceParticipants randomly assigned to this arm will receive contingency management for three weeks to reinforce attendance at all lab visits. Participants will continue to use cannabis as usual. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- >=5 cannabis use days per week on average over the past 3 months
- Female
- >=6 past-year CUD symptoms (must include withdrawal and at least one criterion other than craving must be met within the past 3 months)
- >=20 days of cannabis use over the past 30 days
- Positive urinalysis for THC
Key exclusion criteria (10 listed)
- Current pregnancy
- History of psychotic, seizure, or cardiovascular disorder
- Immediate plan to quit cannabis
- Current treatment for cannabis use
- Current daily psychotropic medication use
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 |
|---|---|---|
| Contingency management for cannabis abstinence and lab visit attendanceEscalating monetary reinforcement is provided for continuous cannabis abstinence and lab visit attendance across the three week study period. | Behavioural | Contingency Management for Cannabis Abstinence and Lab Visit Attendance |
| Contingency management for lab visit attendanceEscalating monetary reinforcement is provided for lab visit attendance across the three week study period. | Behavioural | Contingency Management for Lab Visit Attendance |
Primary outcome
Late Positive Potential
Time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
The Late Positive Potential (neural measure recorded via electroencephalography) will be quantified from ~400 to 3000ms at central-parietal sensors relative to the onset of a cannabis, neutral, unpleasant, or pleasant image. The Late Positive Potential to cannabis vs. neutral and cannabis vs. pleasant will be the primary contrasts of interest.
Reward Positivity
Time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
The Reward Positivity (neural measure recorded via electroencephalography) will be quantified from ~200-300ms at frontal-central sensors relative to the onset of monetary win and loss feedback. The win vs. loss contrast will be the primary outcome of interest.
Eyeblink Startle Response
Time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
The Eyeblink Startle Response (recorded via EMG sensors) will be quantified as the peak blink amplitude relative to the onset of an auditory startle probe during blocks with predictable shocks, unpredictable shocks, and no threat of shock. The Eyeblink Startle Response during unpredictable shock threat vs. no shock threat will be the primary contrast of interest.
2 secondary outcomes
Delta Power
Time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
Delta Intertrial Phase Coherence
Time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-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 5 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management for cannabis abstinence and lab visit attendance and Contingency management for lab visit attendance in people with Cannabis Use Disorder, Severe, run by Florida State 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 6 inclusion and 10 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 5 Aug 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. 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?
Late Positive Potential (time frame: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up). The study lists 3 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 5 Aug 2026.