Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00684554
First received: May 22, 2008
Last updated: April 6, 2016
Last verified: April 2016
Results First Received: May 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Opioid-Related Disorders
Heroin Dependence
Intervention: Drug: Buprenorphine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a structured telephone interview, participants completed in-person screening after obtaining informed consent. Of the 21 patients screened, one was excluded for active alcohol and benzodiazepine dependence.

Reporting Groups
  Description
Unobserved-at Home

Buprenorphine Unobserved at home induction

Buprenorphine: Dose is determined according to the participants' individual need.

Observed

Buprenorphine Observed in office induction

Buprenorphine: Dose is determined according to the participants' individual need.


Participant Flow:   Overall Study
    Unobserved-at Home     Observed  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adult Opioid Dependent treatment seekers

Reporting Groups
  Description
Unobserved-at Home

Buprenorphine Unobserved at home induction

Buprenorphine: Dose is determined according to the participants' individual need.

Observed

Buprenorphine Observed in office induction

Buprenorphine: Dose is determined according to the participants' individual need.

Total Total of all reporting groups

Baseline Measures
    Unobserved-at Home     Observed     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     9     9     18  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.   [ Time Frame: one week after initial primary care visit ]

2.  Secondary:   Prolonged Withdrawal   [ Time Frame: a) 2 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The primary pilot study limitations are sample size and treatment setting, which restricts statistical comparison of outcomes and generalizability.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Frances Levin
Organization: New York State Psychiatric Institute
phone: 646-774-6137
e-mail: frl2@columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00684554     History of Changes
Other Study ID Numbers: #5600
K23DA020000 ( US NIH Grant/Contract Award Number )
Study First Received: May 22, 2008
Results First Received: May 19, 2015
Last Updated: April 6, 2016
Health Authority: United States: Federal Government