Clinical Trial Tobacco Marijuana

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Dartmouth-Hitchcock Medical Center

Washirika

National Institute on Drug Abuse (NIDA)

JARIBIO LA KLINIKI: NCT02277665

BioSeek: NCT02277665

Maneno muhimu

Kikemikali

Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes.

This protocol reflects the planned Stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts. If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.

Tarehe

Imethibitishwa Mwisho:	11/30/2018
Iliyowasilishwa Kwanza:	10/26/2014
Uandikishaji uliokadiriwa Uliwasilishwa:	10/27/2014
Iliyotumwa Kwanza:	10/28/2014
Sasisho la Mwisho Liliwasilishwa:	12/16/2018
Sasisho la Mwisho Lilichapishwa:	01/07/2019
Tarehe ya matokeo ya kwanza yaliyowasilishwa:	11/20/2018
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa:	12/16/2018
Tarehe ya matokeo ya kwanza kuchapishwa:	01/07/2019
Tarehe halisi ya kuanza kwa masomo:	12/17/2014
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	01/17/2017
Tarehe ya Kukamilisha Utafiti:	01/17/2017

Hali au ugonjwa

Cannabis Use Disorder

Tobacco Use Disorder

Uingiliaji / matibabu

Behavioral: CUD Treatment

Behavioral: CUD and Tobacco Treatment

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Active Comparator: CUD Treatment Only 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
Experimental: CUD and Tobacco Treatment 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco	Behavioral: CUD and Tobacco Treatment

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: 1. Individuals must be 18 years or older 2. Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs 3. Individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale) Exclusion Criteria: 1. Current dependence on alcohol or any drug other than tobacco and cannabis 2. Use of non-tobacco nicotine 3. Current participation in structured treatment for substance abuse 4. Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder) 5. Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them 6. Legal status that would interfere with participation 7. Living with someone currently enrolled in the project 8. Not being fluent in English 9. Not living within 45 miles of the research site

Matokeo

Hatua za Matokeo ya Msingi

1. Tobacco Quit Attempts [Week 12]

Percent of Participants who made at least one tobacco quit attempt

2. Tobacco Abstinence [Weeks 9-12]

the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12

3. Cannabis Abstinence [Weeks 1-12]

number of participants who achieved at least one week of documented cannabis abstinence during treatment

4. Weeks of Continuous Cannabis Abstinence [Weeks 1-12]

Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence

5. Treatment Attendance [12 weeks]

Attendance operationalized as the number of clinic visits (urine specimens provided)

6. Initiation of Nicotine Replacement Therapy (NRT) [24 weeks]

# of participants who initiated NRT during the 24 week study period