Heroin DependenceARCNCT00698737
Treatment Study: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
An observational study of Heroin Dependence and Opioid-Related Disorders, run by Wayne State University at 1 site in United States.
Trial summary
This research study takes place at Wayne State University and will take about 11 weeks to complete. This is a treatment research study for individuals who currently have cocaine abuse or dependence, and who may also have heroin dependence. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders, Cocaine Abuse or Dependence
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2012
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Heroin dependent and Cocaine abuse or dependent research volunteers.
Who may be able to join
- Male or non-pregnant and non-lactating females between 18-55 years of age who are seeking treatment for their drug use.
- Females of childbearing potential are eligible to participate if using an acceptable method of birth control.
- All participants must be free from any significant clinical abnormalities based on medical history, physical examination, ECG, and screening laboratory tests.
- Participants must weigh at least 50kg (110lbs).
- Participants must meet DSM-IV criteria for current Cocaine Abuse or Dependence, and possibly Opioid Dependence, and provide a cocaine positive (and, if opioid dependent, opioid positive) urine sample.
- Participants will not be excluded if they meet DSM-IV criteria for current Alcohol or Sedative Abuse (but they will be excluded for current Alcohol or Sedative Dependence).
- Participants must not be under the influence of alcohol (BAL <.002) and sign informed consent during screening.
Who cannot join
- Volunteers will not be eligible for this study if they present with psychiatric illness, neurological disease, cardiovascular disease, pulmonary disease, systemic disease, other current substance dependence (except cocaine, heroin or nicotine).
- If they are cognitively impaired, currently being treated for Cocaine or Opioid Dependence, using prohibited medications, or females who are pregnant, lactating, or if heterosexually active not using medically approved birth control measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
This research study takes place at Wayne State University and will take about 11 weeks to complete. This is a treatment research study for individuals who currently have cocaine abuse or dependence, and who may also have heroin dependence. The purpose of this study is to test whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo for preventing relapse to cocaine use for individuals who abuse or are dependent upon cocaine. We are also interested whether, for patients who are dependent on cocaine and heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination with buprenorphine.
Read the detailed description
Cocaine dependence, particularly in combination with heroin dependence, poses serious and substantial public health, social, and economic problems (e.g., high medical costs, crime, lost productivity). Cocaine and heroin use disorders often co-occur, and this conjunction is associated with higher rates of medical and psychiatric problems and worse drug abuse treatment outcome.
Many medications have been tested, but have failed, for treating cocaine dependence alone or in cocaine abusers who also use heroin.
This clinical trial will test whether SR-AMP is more effective than placebo for preventing relapse to cocaine use, using SR-AMP for patients with only cocaine dependence, or in combination with buprenorphine (for those patients who are also dependent on heroin).
Participants will first be an outpatient and must come to the Jefferson Avenue Research Program three times per week (e.g. Monday, Wednesday, Friday) to measure drug use and drug-related symptoms. This phase will last at least 2 weeks.
Next, participants will live on an inpatient research unit for seven (7) consecutive nights. During the weeklong inpatient stay, in addition to receiving SR-AMP or placebo capsules, participants will begin counseling treatment to help prepare to avoid relapse after they are discharged from the inpatient unit.
After the inpatient stay, participants will then be an outpatient and come to the Jefferson Ave. Research Program daily for eight (8) weeks. Throughout all eight weeks, three urine samples will be collected each week to assess illicit drug use, and questionnaires related to drug symptoms and to assess mood and risk behaviors will be given.
- Keywords
- Opioid, Cocaine
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Cocaine-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698737
- Sponsor's protocol ID
- NIDA 022243-2
- Other IDs
- R01DA022243, DPMCDA
- Acronym
- ARC
- Status last verified
- Nov 2012
- First submitted
- 13 Jun 2008
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.
PubMed 25630964
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
- ClinicalTrials.gov ID
- NCT00698737
- Acronym / sponsor ID
- ARC / NIDA 022243-2
- Keywords
- Opioid, Cocaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Jun 2008 (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 research study takes place at Wayne State University and will take about 11 weeks to complete. This is a treatment research study for individuals who currently have cocaine abuse or dependence, and who may also have heroin dependence. The purpose of this study is to test whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo for preventing relapse to cocaine use for individuals who abuse or are dependent upon cocaine. We are also interested whether, for patients who are dependent on cocaine and heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination with buprenorphine.
Detailed description
Cocaine dependence, particularly in combination with heroin dependence, poses serious and substantial public health, social, and economic problems (e.g., high medical costs, crime, lost productivity). Cocaine and heroin use disorders often co-occur, and this conjunction is associated with higher rates of medical and psychiatric problems and worse drug abuse treatment outcome.
Many medications have been tested, but have failed, for treating cocaine dependence alone or in cocaine abusers who also use heroin.
This clinical trial will test whether SR-AMP is more effective than placebo for preventing relapse to cocaine use, using SR-AMP for patients with only cocaine dependence, or in combination with buprenorphine (for those patients who are also dependent on heroin).
Participants will first be an outpatient and must come to the Jefferson Avenue Research Program three times per week (e.g. Monday, Wednesday, Friday) to measure drug use and drug-related symptoms. This phase will last at least 2 weeks.
Next, participants will live on an inpatient research unit for seven (7) consecutive nights. During the weeklong inpatient stay, in addition to receiving SR-AMP or placebo capsules, participants will begin counseling treatment to help prepare to avoid relapse after they are discharged from the inpatient unit.
After the inpatient stay, participants will then be an outpatient and come to the Jefferson Ave. Research Program daily for eight (8) weeks. Throughout all eight weeks, three urine samples will be collected each week to assess illicit drug use, and questionnaires related to drug symptoms and to assess mood and risk behaviors will be given.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Heroin dependent and Cocaine abuse or dependent research volunteers.
Key inclusion criteria (7 listed)
- Male or non-pregnant and non-lactating females between 18-55 years of age who are seeking treatment for their drug use.
- Females of childbearing potential are eligible to participate if using an acceptable method of birth control.
- All participants must be free from any significant clinical abnormalities based on medical history, physical examination, ECG, and screening laboratory tests.
- Participants must weigh at least 50kg (110lbs).
- Participants must meet DSM-IV criteria for current Cocaine Abuse or Dependence, and possibly Opioid Dependence, and provide a cocaine positive (and, if opioid dependent, opioid positive) urine sample.
Key exclusion criteria (2 listed)
- Volunteers will not be eligible for this study if they present with psychiatric illness, neurological disease, cardiovascular disease, pulmonary disease, systemic disease, other current substance dependence (except cocaine, heroin or nicotine).
- If they are cognitively impaired, currently being treated for Cocaine or Opioid Dependence, using prohibited medications, or females who are pregnant, lactating, or if heterosexually active not using medically approved birth control measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 22 Nov 2012.
- Derived from this study: PubMed 25630964Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.
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.
Mark Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Dependence and Opioid-Related Disorders, run by Wayne State University 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 7 inclusion and 2 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 22 Nov 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698737, which also lists 1 linked publication.
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 22 Nov 2012.