Cocaine DependencePhase 2NCT00777062
VIVITROL as a Treatment for Cocaine and Alcohol Dependence
A Phase 2 study testing VIVITROL (Naltrexone extended-release injectable suspension) in people with Cocaine Dependence and Alcohol Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence, Alcohol Dependence
- What is being tested?
- VIVITROL (Naltrexone extended-release injectable suspension)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 to 65 years old.
- Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
- Meets DSM-IV criteria for Alcohol Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
- Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
- drank within 30 days of intake day,
- reports a minimum of XX standard alcoholic drinks in a consecutive 30-day period over the 90-day period prior to starting intake, and
Show all 26Show fewer
- has 2 or more days of heavy drinking
- In the past 30 days prior to consent, used no less than $ of cocaine.
- Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
- Understands and signs the informed consent.
- Three consecutive days of abstinence from alcohol, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight.
- 4.2 Exclusion Criteria:
- Positive urine drug screen and/or current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, alcohol, or nicotine dependence, as determined by the SCID.
- Concomitant treatment with psychotropic medications, including opioid analgesics.
- Patients mandated to treatment based upon a legal decision or as a condition of employment.
- Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI).
- Taken any investigational medication within the past 30 days.
- History within the six months prior to randomization of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson-White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure). These are to be reviewed on a case-by-case basis: EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <3 x ULN are acceptable).
- Known hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.
- Subjects with a BMI of 40 and above, as determined by the Body Mass Index Table, or that have distribution of adipose tissue such that they would be at greater risk of serious injection site reaction, based on clinical judgment. Participants with a BMI over 30 will have additional screening procedures conducted to determine inclusion in the study. These procedures include an additional screening measurement of waist-hip ratio for those participants with a BMI over 30. Males with a waist to hip ratio of >0.9 and females with a waist to hip ratio of >0.85 will be referred to the investigator for final decision of study inclusion. If the ratio is <0.9 for men or <0.85 for women they will be eligible for study inclusion without further action.
- Patients with any serious illnesses that may require hospitalization during the study.
- Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator.
- Current physiological opioid dependence.
- Experiencing acute opiate withdrawal.
- Likely to receive scheduled surgery, which may require treatment with opioid analgesics.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Randomized, Double-Blind Pilot Trial of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) for the Treatment of Cocaine and Alcohol Dependence
To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence
Read the detailed description
This is a Phase II double-blind randomized controlled clinical pilot study. The exploratory objectives in the proposed study will be examined with a 2-group design to assess the efficacy of naltrexone extended-release injectable suspension (VIVITROL™) as compared to placebo. Safety measures will be collected weekly through medical management (MM) by medical practitioners, including adverse events and concomitant meds. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 80 men and women with current DSM-IV diagnoses of alcohol dependence and cocaine dependence that will be randomized to receive either VIVITROL or placebo (40 subjects per group). All subjects will receive weekly sessions of CBT and MM. The study length for each subject is comprised of 1-3 weeks of screening, an 8-week double-blind, placebo-controlled trial with MM and CBT (medication phase), and an end of medication visit.
Primary Exploratory Objectives:
- To compare medication groups' rates of cocaine abstinence, as determined by urine assay for benzoylecgonine (BE), the primary metabolite of cocaine. This will be cross-checked against participants' self-reports of cocaine use through Time-Line Follow Back (TLFB)(Sobell \& Sobell, 1992).
- To compare medication groups' rates of abstinence from drinking, and of clinically significant drinking, as measured by the TLFB.
Secondary Exploratory Objectives:
- To evaluate medication groups' reports of craving for cocaine and alcohol, as measured by scores on the Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale during the medication treatment phase.
- To compare women's reports of medication tolerance of naltrexone extended-release injectable suspension versus high dose oral naltrexone that was reported in our recently published pilot trial of high dose naltrexone for dual cocaine and alcohol dependence (Pettinati et al., 2008).
- Conditions
- Cocaine Dependence, Alcohol Dependence
- Being tested
- VIVITROL (Naltrexone extended-release injectable suspension), Placebo
- Keywords
- alcohol, cocaine, addiction, alcoholism, substance dependence, substance abuse
- Medical subject headings
- Cocaine-Related Disorders, Alcoholism, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITROL (Naltrexone extended-release injectable suspension)Drug
Also called Vivitrol
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.
PlaceboDrug
Placebo injection at the start of weeks 2 and 6.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 Receives: Drug: VIVITROL (Naltrexone extended-release injectable suspension) |
| 2 | Placebo comparator | Placebo injection, 380 mg injection at the start of weeks 2 and 6. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.
Percentage of subjects with no cocaine use for at least 3 weeks
Measured: 8 week medication phase
Time Line Follow Back -Reported Days of Abstinence From Drinking
Percentage of participants who were abstinent from drinking
Measured: 8 week medication phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kyle Kampman, University of Pennsylvania
- Investigators
- Helen Pettinati, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777062
- Sponsor's protocol ID
- 808641
- Other IDs
- 5P50DA012756-10, DPMC
- Status last verified
- Jan 2018
- First submitted
- 21 Oct 2008
- Last updated
- 26 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind Pilot Trial of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) for the Treatment of Cocaine and Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00777062
- Acronym / sponsor ID
- 808641
- Conditions
- Cocaine Dependence, Alcohol Dependence
- Keywords
- alcohol, cocaine, addiction, alcoholism, substance dependence, substance abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Alkermes, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 29 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence
Detailed description
This is a Phase II double-blind randomized controlled clinical pilot study. The exploratory objectives in the proposed study will be examined with a 2-group design to assess the efficacy of naltrexone extended-release injectable suspension (VIVITROL™) as compared to placebo. Safety measures will be collected weekly through medical management (MM) by medical practitioners, including adverse events and concomitant meds. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 80 men and women with current DSM-IV diagnoses of alcohol dependence and cocaine dependence that will be randomized to receive either VIVITROL or placebo (40 subjects per group). All subjects will receive weekly sessions of CBT and MM. The study length for each subject is comprised of 1-3 weeks of screening, an 8-week double-blind, placebo-controlled trial with MM and CBT (medication phase), and an end of medication visit.
Primary Exploratory Objectives:
- To compare medication groups' rates of cocaine abstinence, as determined by urine assay for benzoylecgonine (BE), the primary metabolite of cocaine. This will be cross-checked against participants' self-reports of cocaine use through Time-Line Follow Back (TLFB)(Sobell \& Sobell, 1992).
- To compare medication groups' rates of abstinence from drinking, and of clinically significant drinking, as measured by the TLFB.
Secondary Exploratory Objectives:
- To evaluate medication groups' reports of craving for cocaine and alcohol, as measured by scores on the Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale during the medication treatment phase.
- To compare women's reports of medication tolerance of naltrexone extended-release injectable suspension versus high dose oral naltrexone that was reported in our recently published pilot trial of high dose naltrexone for dual cocaine and alcohol dependence (Pettinati et al., 2008).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VIVITROL (Naltrexone extended-release injectable suspension)VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo injection, 380 mg injection at the start of weeks 2 and 6. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Males and females, 18 to 65 years old.
- Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
- Meets DSM-IV criteria for Alcohol Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
- Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
- In the past 30 days prior to consent, used no less than $ of cocaine.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VIVITROL (Naltrexone extended-release injectable suspension)Also: VivitrolVIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6. | Drug | 1 |
| PlaceboPlacebo injection at the start of weeks 2 and 6. | Drug | 2 |
Primary outcome
Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.
Time frame: 8 week medication phase
Percentage of subjects with no cocaine use for at least 3 weeks
Time Line Follow Back -Reported Days of Abstinence From Drinking
Time frame: 8 week medication phase
Percentage of participants who were abstinent from drinking
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Pennsylvania Center for the Studies of AddictionLink provided by the sponsor.
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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.
Helen Pettinati, Ph.D. principal investigator
University of Pennsylvania
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 VIVITROL (Naltrexone extended-release injectable suspension) in people with Cocaine Dependence and Alcohol Dependence, run by University of Pennsylvania 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 26 inclusion and 0 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 26 Jan 2018. 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. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine. (time frame: 8 week medication phase). The study lists 2 primary outcomes in all. 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 26 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.