성별/성별 및 CUD 완화
대마초 사용 장애 완화에 대한 성별 및 성 호르몬 영향
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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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. |
|
다른: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants in Remission
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 8 weeks of treatment
|
Number of cannabis use grams assessed via daily diaries during treatment, last 28 days |
8 weeks of treatment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rachel L Tomko, PhD, Medical University of South Carolina
- 수석 연구원: Aimee L McRae-Clark, PharmD, Medical University of South Carolina
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 00110801
- R01DA054617 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .