Phase 4
Completed N=33
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
Source: ClinicalTrials.gov NCT02038790 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Overall Intervention Preference As Assessed by Participants — 54.84; 45.16 percentage of participants — p=>0.5000
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Intervention Preference As Assessed by Participants |
54.84; 45.16 | >0.5000 |
| SECONDARY Participant Preference With Regard to Overall Taste of Interventions |
29.03; 70.97 | 0.0196 sig |
| SECONDARY Participant Assessments With Regard to Ease of Dissolution of Interventions |
19.35; 80.65 | 0.0006 sig |
| SECONDARY Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? |
61.29; 51.61; 38.71; 48.39 | 0.4422 |
| SECONDARY Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? |
100; 90.32; 0; 9.68 | 0.2377 |
| SECONDARY Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? |
54.84; 77.42; 45.16; 22.58 | 0.0603 |
| SECONDARY Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? |
54.84; 96.77; 45.16; 3.23 | <0.0010 sig |
| SECONDARY Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? |
67.74; 58.06; 19.35; 19.35; 6.45; 16.13 | — |
| SECONDARY Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? |
70.97; 70.97; 22.58; 29.03; 3.23; 0 | — |
| SECONDARY Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' |
70.97; 61.29; 16.13; 32.26; 9.68; 6.45 | — |
| SECONDARY Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication |
70.97; 61.29; 16.13; 35.48; 9.68; 3.23 | — |
| SECONDARY Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... |
0; 25.81; 0; 3.23; 100; 70.97 | — |
| SECONDARY Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... |
3.23; 0; 29.03; 51.61; 0; 32.26 | — |
| SECONDARY Dissolution Time of Intervention as Recorded by a Trained Observer |
6.59; 2.98 | — |
| SECONDARY Change From Baseline in Subject Opiate Withdrawal Scale (SOWS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- currently on a single daily dose of 8/2 of Suboxone or generic equivalent, or 5.7/1.4 mg Zubsolv for treatment of opioid dependence that has been medically confirmed.
- in good general health with no specific contraindication for treatment with buprenorphine or naloxone.
- the ability to understand, sign and date written consent and Health Information Portability and Accountability Act (HIPAA) authorization forms, which must be obtained prior to any study related procedures being completed.
- Female subjects must be postmenopausal for at least 2 years, surgically sterile (i.e. tubal ligation, hysterectomy, or bilateral ovariectomy), or practicing an effective method of contraception during the study with one of the following methods: oral contraception, intrauterine device (IUD), abstinence, contraceptive injections, conscientious use of a diaphragm or condoms and spermicidal foam, systemic (implant) contraception or partner has had a vasectomy.
Exclusion Criteria
- Subject is taking other opioids (other than buprenorphine/naloxone) that may interfere with the study evaluations or compromise the safety of the subject.
- Subject is not able to read or have other impairments that may prevent completion of questionnaires or other study evaluations
- Subject has open sores present in the oral cavity.
- Subject has participated in any previous clinical testing involving investigational drug within the 4 weeks prior to study start.
- Subject is pregnant, lactating or planning a pregnancy
- Subject is currently participating in any other type of clinical testing.
- Subject has a medical condition that in the Investigator's opinion could affect the taste assessments required by the study
- Subject is judged by the Investigator after reviewing medical history to be unsuitable for any other reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes.
Data sourced from ClinicalTrials.gov (NCT02038790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.