- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Tallahassee, Florida, Forente stater, 32304
- The BRAINS Lab in the Department of Psychology at Florida State University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Late Positive Potential
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Delta Power
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AUIRB#20-217FB
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .