Cocaine DependencePhase 2CURENCT02003664
A Study of Baclofen ER
A Phase 2 study testing Baclofen ER in people with Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Baclofen ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence.
- Females must be non-pregnant, non- lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence.
- Reading level at or above eighth grade.
- Participants provide voluntary informed consent.
- Smoking is primary route of cocaine administration.
- Available for an inpatient stay.
Who cannot join
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
- Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities.
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
- Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
- Current or prior gambling problems (assessed by participants self-report)
Show all 10Show fewer
- Non-removable skin patches
- Have received medication that could interact adversely with baclofen, including muscle relaxants (including tricyclic antidepressants), antiseizure medication, CNS depressants (tranquilizers, sleeping pills), MAO inhibitors), within the time of administration of study agent based on the study physician's guidance (e.g. 5 half lives)
- Have known or suspected hypersensitivity to baclofen.
- Be taking baclofen for any reason currently or during the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Studies of Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Placebo-controlled Study of Baclofen ER on Brain and Behavioral Outcomes in Cocaine Dependence
This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.
- Conditions
- Cocaine Dependence
- Being tested
- Baclofen ER, Placebo
- Keywords
- Cocaine, Treatment, fMRI, Outcomes
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen ERDrug
Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication
PlaceboDrug
Also called Sugar pill
Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo
| Study group | Role | What they receive |
|---|---|---|
| Baclofen ER versus Placebo | Active comparator | Baclofen ER versus Placebo (sugar pill) Receives: Drug: Baclofen ER |
| Placebo versus Baclofen ER | Placebo comparator | Participants will receive either placebo (sugar pill) or Baclofen ER Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
The primary clinical outcome is number of cocaine-use days (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) during the outpatient treatment and follow-up phases of the study.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: This study never started due to delays in medication development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Rose Childress, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003664
- Sponsor's protocol ID
- 819017
- Acronym
- CURE
- Status last verified
- Sep 2016
- First submitted
- 19 Nov 2013
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Study of Baclofen ER on Brain and Behavioral Outcomes in Cocaine Dependence
- ClinicalTrials.gov ID
- NCT02003664
- Acronym / sponsor ID
- CURE / 819017
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine, Treatment, fMRI, Outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study never started due to delays in medication development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 6 Dec 2013 (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 is a Phase II, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence. The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine brain mechanisms of relapse/recovery, participants will complete fMRI sessions before, during, and after treatment. Brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the 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 |
|---|---|---|
| Baclofen ER versus Placebo | Active comparator | Drug: Baclofen ERBaclofen ER versus Placebo (sugar pill) |
| Placebo versus Baclofen ER | Placebo comparator | Drug: PlaceboParticipants will receive either placebo (sugar pill) or Baclofen ER |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physically healthy cocaine-dependent (based on DSM-IV- TR criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence.
- Females must be non-pregnant, non- lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence.
- Reading level at or above eighth grade.
- Participants provide voluntary informed consent.
- Smoking is primary route of cocaine administration.
Key exclusion criteria (10 listed)
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
- Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities.
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
- Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
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 |
|---|---|---|
| Baclofen ERComparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication | Drug | Baclofen ER versus Placebo |
| PlaceboAlso: Sugar pillComparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo | Drug | Placebo versus Baclofen ER |
Primary outcome
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine)
Time frame: up to 24 weeks
The primary clinical outcome is number of cocaine-use days (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) during the outpatient treatment and follow-up phases of the study.
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 8 Sep 2016.
Related trials for Cocaine Dependence
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission
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.
Anna Rose Childress, PhD 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 Baclofen ER in people with Cocaine 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 6 inclusion and 10 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 8 Sep 2016. 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?
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?
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine) (time frame: up to 24 weeks). 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 8 Sep 2016.