Heroin DependencePhase 2NCT00142948
Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
A Phase 2 study testing Naltrexone in people with Heroin Dependence, run by Baylor College of Medicine at 1 site in Russia.
Trial summary
Naltrexone is a medication that is currently used to treat drug and alcohol addiction. Guanfacine is a medication that is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2006to May 2011
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current primary diagnosis of heroin dependence, for at least 1 year prior to study entry
- High school graduate or higher education level
- Abstinence from drugs and alcohol for at least 1 week prior to study entry
- Negative urine and breathalyzer tests for alcohol and drugs
- No evidence of opioid dependence following narcan challenge
- At least one relative willing to participate in treatment, monitor administration of medications, assist in follow-up, and provide outcome data
Show all 9Show fewer
- Stable address within St. Petersburg or nearest districts of Leningrad Region
- Able to provide a home telephone number where the participant may be reached
- If female, willing to use effective contraception throughout the study
Who cannot join
- Low blood pressure, as determined by sitting blood pressure less than 90/50 mm Hg
- Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder
- Advanced brain, heart, kidney, or liver disease
- Active tuberculosis
- Current febrile illness
- AIDS-defining illness
Show all 13Show fewer
- Significant laboratory abnormality, including severe anemia, unstable diabetes, or liver function tests greater than three times above normal
- Pending legal issues that may entail a jail stay during the study
- Currently participating in another treatment study
- Currently participating in another substance abuse program
- Current use of a psychotropic medication
- Pregnant
- Pulse rate less than 50 bpm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heroin Addiction Treatment: Naltrexone and Adrenergic Agents
Naltrexone is a medication that is currently used to treat drug and alcohol addiction. Guanfacine is a medication that is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. A combination of these two medications may be beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin use in heroin addicts.
Read the detailed description
Heroin addiction is a serious health problem with no available medical treatment for preventing relapse. Naltrexone is a medication that is currently used to treat substance addiction. It acts by blocking the "high" feeling produced by drugs and alcohol. Guanfacine, an antihypertensive medication, is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. While each of these medications is useful in the treatment of heroin addiction, a combination of the two drugs may be more effective than either medication alone. The purpose of this study is to compare the effectiveness of naltrexone, guanfacine, and a combination of naltrexone and guanfacine at reducing drug relapse in heroin addicts.
This study will enroll individuals addicted to heroin who have completed a prior detoxification program at one of two addiction treatment hospitals in St. Petersburg, Russian Federation. Upon completing the detoxification program of 7-14 days, participants will have a period of inpatient rehabilitation. During this 3- to 4-week inpatient stabilization period, patients will be screened for study participation. Once stabilized, participants will begin the 6-month treatment phase of the study. During this phase, they will be randomly assigned to receive one of the following drug combinations on a daily basis: 50 mg of naltrexone and guanfacine placebo; 1.0 mg of guanfacine and naltrexone placebo; 50 mg of naltrexone and 1.0 mg of guanfacine; or naltrexone placebo and guanfacine placebo. All participants will have a designated family member who will be responsible for supervising medication compliance. Study visits will occur twice monthly. Participants will receive clinical management and medication compliance counseling at each visit; family members will also take part in the counseling sessions. Outcome measurements will include drug relapse, medication adherence, withdrawal symptoms, HIV risk factors, and psychiatric symptoms. Follow-up evaluations will occur 3 and 6 months following the end of treatment.
- Conditions
- Heroin Dependence
- Being tested
- Naltrexone, Placebo
- Keywords
- Heroin Abuse, Heroin Addiction
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
naltrexone
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Naltrexone Oral 50 mgs daily Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | 1 to 1 comparison of Naltrexone to placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heroin relapse
Measured: duration of study
Secondary outcomes (4)
HIV risk factors
Measured: baseline
Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations)
Measured: months 6 and the 3- and 6-month follow-up evaluations
Adherence to medication
Measured: duration of study
Heroin withdrawal symptoms
Measured: Month 6, and 3- and 6-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Thomas R. Kosten, MD, Baylor College of Medicine
- Investigators
- Thomas R. Kosten, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142948
- Sponsor's protocol ID
- NIDA-18863
- Other IDs
- R01DA018863, DPMC
- Status last verified
- Oct 2012
- First submitted
- 1 Sep 2005
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heroin Addiction Treatment: Naltrexone and Adrenergic Agents
- ClinicalTrials.gov ID
- NCT00142948
- Acronym / sponsor ID
- NIDA-18863
- Conditions
- Heroin Dependence
- Keywords
- Heroin Abuse, Heroin Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Sep 2005 (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.
Naltrexone is a medication that is currently used to treat drug and alcohol addiction. Guanfacine is a medication that is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. A combination of these two medications may be beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin use in heroin addicts.
Detailed description
Heroin addiction is a serious health problem with no available medical treatment for preventing relapse. Naltrexone is a medication that is currently used to treat substance addiction. It acts by blocking the "high" feeling produced by drugs and alcohol. Guanfacine, an antihypertensive medication, is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. While each of these medications is useful in the treatment of heroin addiction, a combination of the two drugs may be more effective than either medication alone. The purpose of this study is to compare the effectiveness of naltrexone, guanfacine, and a combination of naltrexone and guanfacine at reducing drug relapse in heroin addicts.
This study will enroll individuals addicted to heroin who have completed a prior detoxification program at one of two addiction treatment hospitals in St. Petersburg, Russian Federation. Upon completing the detoxification program of 7-14 days, participants will have a period of inpatient rehabilitation. During this 3- to 4-week inpatient stabilization period, patients will be screened for study participation. Once stabilized, participants will begin the 6-month treatment phase of the study. During this phase, they will be randomly assigned to receive one of the following drug combinations on a daily basis: 50 mg of naltrexone and guanfacine placebo; 1.0 mg of guanfacine and naltrexone placebo; 50 mg of naltrexone and 1.0 mg of guanfacine; or naltrexone placebo and guanfacine placebo. All participants will have a designated family member who will be responsible for supervising medication compliance. Study visits will occur twice monthly. Participants will receive clinical management and medication compliance counseling at each visit; family members will also take part in the counseling sessions. Outcome measurements will include drug relapse, medication adherence, withdrawal symptoms, HIV risk factors, and psychiatric symptoms. Follow-up evaluations will occur 3 and 6 months following the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: NaltrexoneNaltrexone Oral 50 mgs daily |
| Placebo | Placebo comparator | Drug: Placebo1 to 1 comparison of Naltrexone to placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Current primary diagnosis of heroin dependence, for at least 1 year prior to study entry
- High school graduate or higher education level
- Abstinence from drugs and alcohol for at least 1 week prior to study entry
- Negative urine and breathalyzer tests for alcohol and drugs
- No evidence of opioid dependence following narcan challenge
Key exclusion criteria (13 listed)
- Low blood pressure, as determined by sitting blood pressure less than 90/50 mm Hg
- Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder
- Advanced brain, heart, kidney, or liver disease
- Active tuberculosis
- Current febrile illness
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 |
|---|---|---|
| Naltrexonenaltrexone | Drug | Naltrexone |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Heroin relapse
Time frame: duration of study
4 secondary outcomes
HIV risk factors
Time frame: baseline
Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations)
Time frame: months 6 and the 3- and 6-month follow-up evaluations
Adherence to medication
Time frame: duration of study
Heroin withdrawal symptoms
Time frame: Month 6, and 3- and 6-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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.
Thomas R. Kosten, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Heroin Dependence, run by Baylor College of Medicine at 1 site in Russia.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 24 Oct 2012. 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 Russia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heroin relapse (time frame: duration of study). 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 24 Oct 2012.