Tobacco Intervention in Buprenorphine Treatment (IBIS)
This study is currently recruiting participants.
Verified January 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
Sharon Hall, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01350011
First received: May 5, 2011
Last updated: January 29, 2013
Last verified: January 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 5, 2011 | ||||||||
| Last Updated Date | January 29, 2013 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Smoking Status [ Time Frame: 3, 6, 12, and 18 Months ] [ Designated as safety issue: No ] Smoking status is defined as "no cigarettes for the past 7 days." |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01350011 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Tobacco Intervention in Buprenorphine Treatment | ||||||||
| Official Title ICMJE | Extended Tobacco Dependence Intervention in Buprenorphine Treatment | ||||||||
| Brief Summary | Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The specific aims of the study are to test the efficacy and the cost effectiveness of the IS. A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Tobacco Dependence | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | April 2015 | ||||||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01350011 | ||||||||
| Other Study ID Numbers ICMJE | P030871, P50DA009253 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sharon Hall, University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | January 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||