Geslacht/geslacht & CUD-remissie
Invloeden van geslacht en geslachtshormonen op de remissie van cannabisgebruiksstoornissen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
South Carolina
-
Charleston, South Carolina, Verenigde Staten, 29425
- Medical University of South Carolina
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: 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. |
|
Ander: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of Participants in Remission
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 8 weeks of treatment
|
Number of cannabis use grams assessed via daily diaries during treatment, last 28 days |
8 weeks of treatment
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rachel L Tomko, PhD, Medical University of South Carolina
- Hoofdonderzoeker: Aimee L McRae-Clark, PharmD, Medical University of South Carolina
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
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Lymfoom, non-Hodgkin
- Lymfoom
- Hemische en lymfatische ziekten
- Lymfoom, folliculair
- Gedragstherapie
- Psychotherapie
- Gedragsdisciplines en activiteiten
- Cognitieve gedragstherapie
Andere studie-ID-nummers
- 00110801
- R01DA054617 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
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 .