Opiate AddictionPhase 4NCT01015066
Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents
A Phase 4 study testing Buprenorphine/naloxone and Naltrexone in people with Opiate Addiction, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Buprenorphine/naloxone and Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical Diagnosis of Opiate Dependence
- Successful completion of detoxification
- can answer 9 out of 10 question correctly that tests understanding of the study
Who cannot join
- unable to pay for medication
- not living with a parent/guardian
- inability of patient and/or parent to give consent
- major co-occurring psychiatric disorder
- existing medical condition that would interfere with the treatment
- use of CNS depressants
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UB Department of Family Medicine
Buffalo, New York, 14203
About this study
Official title: A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.
Read the detailed description
Context: Standard treatment of opioid dependence in adolescents is detoxification and counseling, which results in relapse in 20-50% of patients. Alternative medical treatments include buprenorphine and naltrexone that have not been well investigated in adolescents and young adults. Buprenorphine has previously been shown effective in the treatment of opioid dependence in adolescents in one study in the United States as compared to detoxification. Although naltrexone treatment results in low compliance in adults, it is effective in combination with a strong social support network that exists in adolescents that live with at least 1 parent/guardian.
Objective: To compare the efficacy of buprenorphine/naloxone pharmacotherapy with naltrexone pharmacotherapy on treatment retention, relapse prevention and craving reduction among opioid-addicted adolescents and young adults.
Design: 2-arm Randomized Comparative Effectiveness Pharmacotherapy Clinical Trial.
Setting: The study will be conducted in an outpatient treatment facility Participants: The participants will be those who 1) are between 16-25 years old, 2) have clear evidence of a substance use disorder with opioid dependence, and 3) live with at least one parent.
Baseline data collection: Data collected at baseline will include (with examples), demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), co-existing medical problems (seizures, hepatitis C), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (DAST, opioid craving score).
Outcome data: Four main outcomes will be examined: Retention in treatment, self-reported opioid craving, self-reported drug use with urine toxicology confirmation. Retention in treatment (1-180 days) will be measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment. Opioid carving (1-10) will be measured by a 10 point visual analog scale. Self-reported drug use (days to first use and percent days abstinent) will be measured by time line follow back. Urine toxicology (yes/no) will be determined at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Data analysis: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).
- Conditions
- Opiate Addiction
- Being tested
- Buprenorphine/naloxone, Naltrexone
- Keywords
- drug dependence, substance abuse, substance use disorders, buprenorphine, naltrexone, adolescents
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/naloxoneDrug
Also called Suboxone
Sublingual tablets, 2/0.5mg (ratio buprenorphine:naloxone = 4:1), three times a day for six months (doses may be adjusted based on an individual's response)
NaltrexoneDrug
Also called ReVia
Oral tables, 50 mg/d, once a day for six months
| Study group | Role | What they receive |
|---|---|---|
| buprenophine/naloxone | Active comparator | Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone). Receives: Drug: Buprenorphine/naloxone |
| Naltrexone | Experimental | Participants assigned to this arm will receive 50 mg/d naltrexone. Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment.
Measured: 6 months
Secondary outcomes (3)
Opioid craving: (1-10) as measured by a 10 point visual analog scale.
Measured: 6 months
Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.
Measured: 6 months
Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Study personnel left institution, anticipated funding did not occur
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Blondell, State University of New York at Buffalo
- Investigators
- Richard D Blondell, MD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015066
- Sponsor's protocol ID
- FMD04405009B
- Status last verified
- Jun 2014
- First submitted
- 15 Oct 2009
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT01015066
- Acronym / sponsor ID
- FMD04405009B
- Conditions
- Opiate Addiction
- Keywords
- drug dependence, substance abuse, substance use disorders, buprenorphine, naltrexone, adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study personnel left institution, anticipated funding did not occur
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.
Detailed description
Context: Standard treatment of opioid dependence in adolescents is detoxification and counseling, which results in relapse in 20-50% of patients. Alternative medical treatments include buprenorphine and naltrexone that have not been well investigated in adolescents and young adults. Buprenorphine has previously been shown effective in the treatment of opioid dependence in adolescents in one study in the United States as compared to detoxification. Although naltrexone treatment results in low compliance in adults, it is effective in combination with a strong social support network that exists in adolescents that live with at least 1 parent/guardian.
Objective: To compare the efficacy of buprenorphine/naloxone pharmacotherapy with naltrexone pharmacotherapy on treatment retention, relapse prevention and craving reduction among opioid-addicted adolescents and young adults.
Design: 2-arm Randomized Comparative Effectiveness Pharmacotherapy Clinical Trial.
Setting: The study will be conducted in an outpatient treatment facility Participants: The participants will be those who 1) are between 16-25 years old, 2) have clear evidence of a substance use disorder with opioid dependence, and 3) live with at least one parent.
Baseline data collection: Data collected at baseline will include (with examples), demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), co-existing medical problems (seizures, hepatitis C), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (DAST, opioid craving score).
Outcome data: Four main outcomes will be examined: Retention in treatment, self-reported opioid craving, self-reported drug use with urine toxicology confirmation. Retention in treatment (1-180 days) will be measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment. Opioid carving (1-10) will be measured by a 10 point visual analog scale. Self-reported drug use (days to first use and percent days abstinent) will be measured by time line follow back. Urine toxicology (yes/no) will be determined at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Data analysis: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buprenophine/naloxone | Active comparator | Drug: Buprenorphine/naloxoneParticipants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone). |
| Naltrexone | Experimental | Drug: NaltrexoneParticipants assigned to this arm will receive 50 mg/d naltrexone. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical Diagnosis of Opiate Dependence
- Successful completion of detoxification
- can answer 9 out of 10 question correctly that tests understanding of the study
Key exclusion criteria (7 listed)
- unable to pay for medication
- not living with a parent/guardian
- inability of patient and/or parent to give consent
- major co-occurring psychiatric disorder
- existing medical condition that would interfere with the treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine/naloxoneAlso: SuboxoneSublingual tablets, 2/0.5mg (ratio buprenorphine:naloxone = 4:1), three times a day for six months (doses may be adjusted based on an individual's response) | Drug | buprenophine/naloxone |
| NaltrexoneAlso: ReViaOral tables, 50 mg/d, once a day for six months | Drug | Naltrexone |
Primary outcome
Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment.
Time frame: 6 months
3 secondary outcomes
Opioid craving: (1-10) as measured by a 10 point visual analog scale.
Time frame: 6 months
Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.
Time frame: 6 months
Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Blondell, MD principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/naloxone and Naltrexone in people with Opiate Addiction, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.