- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07746440
Impact of Cannabis Use and Abstinence on Emotion (ICAE)
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?
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
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Florida
-
Tallahassee, Florida, Verenigde Staten, 32304
- The BRAINS Lab in the Department of Psychology at Florida State University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- >=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
Exclusion Criteria:
- 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
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Contingency Management for Cannabis Abstinence and Lab Visit Attendance
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.
|
Escalating monetary reinforcement is provided for continuous cannabis abstinence and lab visit attendance across the three week study period.
|
|
Ander: Contingency Management for Lab Visit Attendance
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.
|
Escalating monetary reinforcement is provided for lab visit attendance across the three week study period.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Late Positive Potential
Tijdsspanne: 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.
|
Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
|
Reward Positivity
Tijdsspanne: 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.
|
Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
|
Eyeblink Startle Response
Tijdsspanne: 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.
|
Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Delta Power
Tijdsspanne: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
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.
|
Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
|
Delta Intertrial Phase Coherence
Tijdsspanne: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
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.
|
Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- AUIRB#20-217FB
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .