Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

• Sponsor: Indivior Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00684073
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Duration (Months): 5

Study Details

Study Description

Brief Summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

Condition or Disease	Intervention/Treatment	Phase
Opiate-related Disorders; Opiate Dependence; Drug Abuse	Drug: buprenorphine; Drug: buprenorphine/naloxone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Preference for a Buprenorphine-based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphine/Naloxone Combination (Suboxone®), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Subutex®/Suboxone® Subutex® for first two days of study followed by Suboxone® for last 3 days of study

Drug: buprenorphine; 2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study; Other Names: Subutex®; SCH 028444 ; Drug: buprenorphine/naloxone; 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study; Other Names: Suboxone®; SCH 000484

Outcome Measures

Primary Outcome Measures

1. Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). [Each treatment Day (post-dose on days 1-5)]

   Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

• Subject must be at least (>=) 18 years of age, of either sex.

• Subject treated for opioid dependence with Subutex® with a stable daily dose between 2 mg and 16 mg daily, for at least 6 months.

• Subject who do not inject/misuse their treatment with Subutex®.

• Subject must be free of illicit opiate drug use as assessed by urine test performed prior to inclusion.

• Subject must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications / products and adverse events to the investigator or designee.

• Women of childbearing potential (includes women who are less than one year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterile (e.g., hysterectomy or tubal ligation).

• Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. Women of childbearing potential must have a urine pregnancy test with negative result within 2 weeks prior to inclusion (as performed under control of the investigator or designee).

Exclusion Criteria:

• Subject not eligible for treatment with Subutex® or Suboxone® according to the legal drug attachments.

• Subject refusing to take the daily dose of the study medication under control in the center.

• Subject unable to complete the evaluations.

• Women who are pregnant or nursing.

• Subject with a history of hypersensitivity to buprenorphine hydrochloride or naloxone hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.

• Subject with a current evidence of alcohol abuse.

• Subject with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens .

• Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.

• Initiation or increase in the dose, within the past 7 days or scheduled during the study, of a treatment with:

• benzodiazepines,

• other depressants of the central nervous system: other morphine derivatives (analgesics, antitussives), certain antidepressive agents, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and clonidine-like agents and monoamine oxidase [MAO] inhibitors,

• CYP3A4 inhibitors,

• CYP3A4 inducers.

• Subjects who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.

• Subjects who have used any investigational product within 30 days prior to enrollment.

• Subjects participating in another trial at the same time.

• Subject who intend to donate blood during the study or within 3 months after study completion.

• Subjects in the exclusion period of the "Fichier National des Personnes qui se Prêtent à des Recherches Biomédicales" (National Index of Persons Participating in Biomedical Researches, or National Index of Volunteers).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Indivior Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00684073
• Other Study ID Numbers: P05094; 2006-006686-17
• First Posted: May 26, 2008
• Last Update Posted: Apr 19, 2011
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Suboxone; Subutex; Buprenorphine; Naloxone
• Additional relevant MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

Participant Flow

Pre-assignment Detail	60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent

Arm/Group Title	Subutex®/Suboxone®
Arm/Group Description	Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Period Title: Selection
STARTED	60
COMPLETED	53
NOT COMPLETED	7
Period Title: Selection
STARTED	53
COMPLETED	52
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Subutex®/Suboxone®
Arm/Group Description	Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Overall Participants	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.9 (8.6)
Sex: Female, Male (Count of Participants)
Female	15 28.3%
Male	38 71.7%

Outcome Measures

1. Primary Outcome

Title	Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).
Description	Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"
Time Frame	Each treatment Day (post-dose on days 1-5)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.

Arm/Group Title	Day 1 (Subutex®)	Day 2 (Subutex®)	Day 3 (Suboxone®)	Day 4 (Suboxone®)	Day 5 (Suboxone®)
Arm/Group Description	All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study	All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
Measure Participants	53	53	53	53	53
Mean (Standard Deviation) [centimeters]	7.04 (2.24)	6.83 (2.18)	7.38 (1.93)	6.89 (2.48)	7.12 (2.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Day 1 (Subutex®), Day 2 (Subutex®), Day 3 (Suboxone®), Day 4 (Suboxone®), Day 5 (Suboxone®)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.130
	Comments	p-value adjusted for treatment only
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.42
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.

Adverse Events

Arm/Group Title	Subutex®/Suboxone®
Arm/Group Description	Subutex® for first two days of study followed by Suboxone® for last 3 days of study
All Cause Mortality
	Subutex®/Suboxone®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subutex®/Suboxone®
	Affected / at Risk (%)	# Events
Total	0/53 (0%)
Other (Not Including Serious) Adverse Events
	Subutex®/Suboxone®
	Affected / at Risk (%)	# Events
Total	8/53 (15.1%)
General disorders
Fatigue	4/53 (7.5%)	4
Nervous system disorders
Headache	3/53 (5.7%)	3
Skin and subcutaneous tissue disorders
Hyperhidrosis	3/53 (5.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor agreement is always necessary before PI publishing or communications. The sponsor can review the communication project during 28 days. The sponsor can require changes to the communication and can extend the embargo.