Køn/Sex & CUD Remission
Køns- og kønshormonpåvirkninger på remission af cannabisbrug
Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care).
- Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder.
- Submit a positive urine cannabinoid test during screening.
- Interested in treatment for cannabis use disorder.
Exclusion Criteria:
- Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation.
- The presence of any substance use disorder requiring a higher level of care.
- Significant risk of homicide or suicide.
- Pregnant, trying to become pregnant, or breastfeeding.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Cognitive Behavioral Therapy - Males
112 male participants were enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They received a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. |
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT. |
|
Andet: Cognitive Behavioral Therapy - Females
112 female participants were enrolled in 8 weeks of behavioral treatment for cannabis use disorder (CUD). They received a motivational interviewing session with a therapist followed by 7 weekly online modules of CBT4CBT with continued monitoring and support from a therapist. |
Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants in Remission
Tidsramme: Week 4
|
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview. |
Week 4
|
|
Proportion of Participants in Remission
Tidsramme: Week 8
|
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview. |
Week 8
|
|
Proportion of Participants in Remission
Tidsramme: Week 12
|
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview. |
Week 12
|
|
Proportion of Participants in Remission
Tidsramme: Week 16
|
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview. |
Week 16
|
|
Proportion of Participants in Remission
Tidsramme: Week 20
|
Remission is classified as the absence of DSM-5 cannabis use disorder symptoms (except cravings) as measured by semi-structured diagnostic interview. |
Week 20
|
|
Reduction in Cannabis Use Days
Tidsramme: 8 weeks of treatment
|
Number of cannabis use days assessed via daily diaries during treatment, past 28 days |
8 weeks of treatment
|
|
Reduction in Cannabis Use Episodes
Tidsramme: 8 weeks of treatment
|
Number of cannabis use grams assessed via daily diaries during treatment, last 28 days |
8 weeks of treatment
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rachel L Tomko, PhD, Medical University of South Carolina
- Ledende efterforsker: Aimee L McRae-Clark, PharmD, Medical University of South Carolina
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Hemiske og lymfatiske sygdomme
- Lymfom, follikulært
- Adfærdsterapi
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Kognitiv adfærdsterapi
Andre undersøgelses-id-numre
- 00110801
- R01DA054617 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Investigators support data sharing as essential for scientific advancement. It is expected that primary outcome papers will be completed and submitted to appropriate peer-reviewed scientific journals within 180 days of data lock. Requests for data from this project by individuals outside of the research team will be reviewed by the team following data lock. Data sharing will adhere to all provisions of the Health Insurance Portability and Accountability Act (HIPAA) and the rights and privacy of people who participate in research will be protected at all times. The requesting Investigator must specify the subset of variables needed or provide a detailed justification of why the complete dataset is absolutely necessary. Data made available to other investigators will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
IPD-delingstidsramme
Requests for data from this project by individuals outside of the research team will be reviewed by the team 180 days after study completion.
IPD-delingsadgangskriterier
The requesting Investigator must specify the subset of variables needed. Data made available to other investigators will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Data will be shared via CSV file or other requested formats, if the study team is able to accommodate the alternative requested format.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .