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A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00604188
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : May 6, 2011
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Opiate Dependence
Drug Dependence
Substance Dependence
Interventions: Drug: Suboxone (SCH 000484)
Drug: Subutex (SCH 028444)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
188 participants were recruited in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
188 participants were randomized in the study; however one did not receive any study medication. Therefore the intent-to-treat (ITT) population was 187 participants.

Reporting Groups
  Description
Direct Suboxone Induction Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
Subutex-to-Suboxone Induction Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.

Participant Flow:   Overall Study
    Direct Suboxone Induction   Subutex-to-Suboxone Induction
STARTED   93   95 [1] 
COMPLETED   66   70 
NOT COMPLETED   27   25 
Adverse Event                1                4 
Lost to Follow-up                17                15 
Withdrawal by Subject                5                1 
Non-compliance with protocol                4                4 
Did not receive study drug                0                1 
[1] The ITT population for Subutex-to-Suboxone Induction is 94 participants



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Direct Suboxone Induction Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
Subutex-to-Suboxone Induction Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
Total Total of all reporting groups

Baseline Measures
   Direct Suboxone Induction   Subutex-to-Suboxone Induction   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   94   187 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (8.4)   30.5  (8.2)   30.7  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  22.6%      25  26.6%      46  24.6% 
Male      72  77.4%      69  73.4%      141  75.4% 


  Outcome Measures

1.  Primary:   Responders at Day 3   [ Time Frame: 3 days ]

2.  Secondary:   Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)   [ Time Frame: 28 days ]

3.  Secondary:   Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)   [ Time Frame: Days 3 to 28 ]

4.  Secondary:   Self-reported Opioid Withdrawal Symptoms (SOWS)   [ Time Frame: Baseline and 28 days ]

5.  Secondary:   Observer-rated Opioid Withdrawal Symptoms (OOWS)   [ Time Frame: Baseline and 28 days ]

6.  Secondary:   Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric   [ Time Frame: Baseline and 28 days ]

7.  Secondary:   Compliance Rate   [ Time Frame: 28 days ]

8.  Secondary:   Responders at Day 28   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00604188     History of Changes
Other Study ID Numbers: P05042
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: December 7, 2010
Results First Posted: May 6, 2011
Last Update Posted: July 2, 2017