Cocaine-Related DisordersPhase 2NCT00082485
Baclofen for the Treatment of Cocaine Dependence - 1
A Phase 2 study testing Baclofen in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 8 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2004to Jul 2006
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have DSM-IV diagnosis of cocaine dependence.
- Subject must be seeking treatment for cocaine dependence.
- Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.
Who cannot join
- Please contact site for more information.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
VA Maryland Healthcare System
Baltimore, Maryland, 21201
Denver VA Medical Center
Denver, Colorado, 80220
Institute of Resch & Educ Inova Fairfax Hospital
Falls Church, Virginia, 22042 3300
U of Penn School of Medicine
Philadelphia, Pennsylvania, 19104 6178
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
South TX VA Health Care System
San Antonio, Texas, 78284 4404
San Francisco General Hosptial
San Francisco, California, 94110
Torrance Site
Torrance, California, 90502
About this study
Official title: Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.
Read the detailed description
Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence
- Conditions
- Cocaine-Related Disorders
- Being tested
- Baclofen, Placebo
- Keywords
- Cocaine Dependence
- 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.
BaclofenDrug
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Baclofen |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of medication on cocaine craving
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2004 (estimated)
- Study startJun 2004
- Primary completionJul 2006
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 Cocaine-Related DisordersStudies 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
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Liza Gorgon, M.A., Principal investigator, VA Maryland Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082485
- Sponsor's protocol ID
- NIDA-CSP-1021-1
- Status last verified
- Aug 2016
- First submitted
- 11 May 2004
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.
PubMed 19414226
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00082485
- Acronym / sponsor ID
- NIDA-CSP-1021-1
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Jul 2006 (actual)
- First posted
- 12 May 2004 (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.
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.
Detailed description
Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence
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 |
|---|---|---|
| 1 | Active comparator | Drug: Baclofen |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have DSM-IV diagnosis of cocaine dependence.
- Subject must be seeking treatment for cocaine dependence.
- Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.
Key exclusion criteria (1 listed)
- Please contact site for more information.
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 |
|---|---|---|
| BaclofenDose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8) | Drug | 1 |
| PlaceboPlacebo | Other | 2 |
Primary outcome
Effects of medication on cocaine craving
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 12 Jan 2017.
- Results publication: PubMed 19414226Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.
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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.
Liza Gorgon, M.A. principal investigator
VA Maryland Health Care System
8 sites 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 in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 8 sites 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 1 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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?
Effects of medication on cocaine craving. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082485, 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 12 Jan 2017.