Cocaine Related DisordersPhase 1NCT01148992
Interactions Between Intravenous (IV) Cocaine and Lofexidine
A Phase 1 study testing Lofexidine in people with Cocaine Related Disorders, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Related Disorders
- What is being tested?
- Lofexidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
- Be between 18 and 50 years of age, inclusive.
- Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
- Be able to verbalize understanding of the consent form and provide written informed consent.
- Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:
- diaphragm and condom by partner
Show all 10Show fewer
- intrauterine device (that does not contain progesterone) and condom by partner
- sponge and condom by partner
- complete abstinence from sexual intercourse
- Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.
Who cannot join
- Please contact site for more information
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
California Pacific Medical Center Research Institute
San Francisco, California, 94110
About this study
Official title: Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Read the detailed description
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
- Conditions
- Cocaine Related Disorders
- Being tested
- Lofexidine, Placebo
- 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.
LofexidineDrug
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
PlaceboDrug
0mg
| Study group | Role | What they receive |
|---|---|---|
| Lofexidine | Active comparator | Not described Receives: Drug: Lofexidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event and Cardiovascular Response
Adverse Events will measured during follow-up at weeks 14-21
Measured: Daily, up to 9 days
Secondary outcomes (4)
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Measured: Daily, up to 9 days
PK of Lofexidine
Measured: Daily, up to 9 days
Visual Analog Scale (VAS)
Measured: Daily, up to 9 days
Brief Substance Abuse Craving Scale (BSCA)
Measured: Daily, up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148992
- Sponsor's protocol ID
- Lofexidine-0001
- Status last verified
- Aug 2016
- First submitted
- 17 Jun 2010
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
- ClinicalTrials.gov ID
- NCT01148992
- Acronym / sponsor ID
- Lofexidine-0001
- Conditions
- Cocaine Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Jun 2010 (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 potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Detailed description
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
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 |
|---|---|---|
| Lofexidine | Active comparator | Drug: Lofexidine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
- Be between 18 and 50 years of age, inclusive.
- Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
- Be able to verbalize understanding of the consent form and provide written informed consent.
- Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:
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 |
|---|---|---|
| Lofexidine0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg | Drug | Lofexidine |
| Placebo0mg | Drug | Placebo |
Primary outcome
Adverse Event and Cardiovascular Response
Time frame: Daily, up to 9 days
Adverse Events will measured during follow-up at weeks 14-21
4 secondary outcomes
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time frame: Daily, up to 9 days
PK of Lofexidine
Time frame: Daily, up to 9 days
Visual Analog Scale (VAS)
Time frame: Daily, up to 9 days
Brief Substance Abuse Craving Scale (BSCA)
Time frame: Daily, up to 9 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lofexidine in people with Cocaine Related Disorders, run by National Institute on Drug Abuse (NIDA) at 2 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 10 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: stopped early, as of the sponsor's last update on 11 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 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early. Results are not available in the source record.
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?
Adverse Event and Cardiovascular Response (time frame: Daily, up to 9 days). 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 11 Jan 2017.