Cocaine DependencePhase 2CAMPRALNCT00385268
Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
A Phase 2 study testing acamprosate in people with Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females 18 years of age or older.
- Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined by The Structured Clinical Interview for DSM-IV (SCID-IV).
- Subject used cocaine in the past 30 days totaling at least $200 worth of cocaine. Cocaine use will be determined by utilizing the modified Timeline Followback, crosschecked with the ASI, which inquires about dollar amounts spent on drug use.
- Subject lives a commutable distance from the TRC and agrees to attend all research visits, including follow-up visits.
- Subject speaks, understands, and prints in English.
- Written informed consent signed by the subject.
Who cannot join
- Subjects mandated to treatment based upon a legal decision or as a condition of employment.
- Subjects with evidence of current substance dependence other than cocaine, alcohol or nicotine dependence, as determined by the SCID-IV.
- Subjects who meets DSM-IV criteria for current alcohol dependence who require a medical alcohol detoxification.
- Requires treatment with any psychoactive medications, including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any psychotic disorder, or organic mental disorder. Has current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).
- Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, and oral contraceptives.
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- Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG-1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] < 5 x ULN are acceptable. Eligibility will be determined by most recent lab results collected prior to randomization.
- Subjects with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (Center for Disease Control, 1986).
- Subjects who have any disease of the gastrointestinal tract, liver or kidneys that could result in a possibility of altered metabolism or excretion of the study drug. As it is not possible to enumerate the many conditions which might impair absorption, metabolism, or excretion, the investigators will be guided by evidence such as: History of major gastrointestinal tract surgery (gastrectomy, gastrostomy, bowel resection, etc) or a history of an active peptic ulcer or chronic disease of the GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).
- History of significant heart disease (an arrhythmia which required medication, angina pectoris, documented history of myocardial infarction, or heart failure).
- Known hypersensitivity to acamprosate.
- Subjects having participated in any investigational drug trial within 30 days prior to randomizing into the study.
- Subjects with any serious illnesses that may require hospitalization during the study, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).
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, Double-Blind, Placebo-controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.
Read the detailed description
The primary objective of the trial is to evaluate the safety, tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients. The study will be an exploratory, double-blind, placebo-controlled 9-week trial, with a 2-cell design (30 subjects per cell) in which either 1998 mg/day of acamprosate (666 mg TID) or placebo will be given. Study medications will be given by medical practitioners, trained to provide NIAAA's COMBINE Medical Management. In addition, patients will receive weekly individual psychosocial treatment sessions utilizing Cognitive Behavioral Therapy (CBT) at the University of Pennsylvania Treatment Research Center (TRC).
Primary Hypotheses:
- Efficacy: Acamprosate-treated subjects will demonstrate less cocaine use during the medication/placebo treatment phase, compared to placebo-treated subjects. Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine (BE)
- Safety and Tolerability: Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events, assessed by weekly evaluations, physical exams and laboratory testing.
Secondary Hypotheses:
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report less craving for cocaine, measured by lower scores on the Brief Substance Craving Scale (BSCS) (Somoza et al, 1995) and Multiple Choice Procedure (MCP) (Griffiths et al., 1993) during the medication treatment phase.
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer withdrawal symptoms, measured by the Cocaine Selective Severity Assessment (Kampman et al., 1998).
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer mood and anxiety symptoms, measured by the Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1967), Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1969), and Clinical Global Impression Scale (CGI).
- Subjects who are highly acamprosate-adherent (>80% pills taken, verified by combining patient report with blister cards) will have more cocaine non-use days during the medication treatment phase, compared to those who are less acamprosate-adherent (<80% pills taken).
- Conditions
- Cocaine Dependence
- Being tested
- acamprosate, placebo
- Keywords
- cocaine
- 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.
acamprosateDrug
Also called Campral
1998 mg/dau fpr 8 weeks
placeboDrug
placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Active medication Acamprosate | Experimental | 1998mg/day for 8 weeks Receives: Drug: acamprosate |
| Placebo | Placebo comparator | placebo pills for 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen
cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2008
- Study completionJul 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT00385268
- Sponsor's protocol ID
- 803895
- Other IDs
- P60DA005186, DPMC
- Acronym
- CAMPRAL
- Status last verified
- Sep 2018
- First submitted
- 6 Oct 2006
- Last updated
- 10 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00385268
- Acronym / sponsor ID
- CAMPRAL / 803895
- Conditions
- Cocaine Dependence
- Keywords
- cocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Posted 31 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.
Detailed description
The primary objective of the trial is to evaluate the safety, tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients. The study will be an exploratory, double-blind, placebo-controlled 9-week trial, with a 2-cell design (30 subjects per cell) in which either 1998 mg/day of acamprosate (666 mg TID) or placebo will be given. Study medications will be given by medical practitioners, trained to provide NIAAA's COMBINE Medical Management. In addition, patients will receive weekly individual psychosocial treatment sessions utilizing Cognitive Behavioral Therapy (CBT) at the University of Pennsylvania Treatment Research Center (TRC).
Primary Hypotheses:
- Efficacy: Acamprosate-treated subjects will demonstrate less cocaine use during the medication/placebo treatment phase, compared to placebo-treated subjects. Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine (BE)
- Safety and Tolerability: Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events, assessed by weekly evaluations, physical exams and laboratory testing.
Secondary Hypotheses:
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report less craving for cocaine, measured by lower scores on the Brief Substance Craving Scale (BSCS) (Somoza et al, 1995) and Multiple Choice Procedure (MCP) (Griffiths et al., 1993) during the medication treatment phase.
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer withdrawal symptoms, measured by the Cocaine Selective Severity Assessment (Kampman et al., 1998).
- Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer mood and anxiety symptoms, measured by the Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1967), Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1969), and Clinical Global Impression Scale (CGI).
- Subjects who are highly acamprosate-adherent (>80% pills taken, verified by combining patient report with blister cards) will have more cocaine non-use days during the medication treatment phase, compared to those who are less acamprosate-adherent (<80% pills taken).
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 |
|---|---|---|
| Active medication Acamprosate | Experimental | Drug: acamprosate1998mg/day for 8 weeks |
| Placebo | Placebo comparator | Drug: placeboplacebo pills for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and females 18 years of age or older.
- Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined by The Structured Clinical Interview for DSM-IV (SCID-IV).
- Subject used cocaine in the past 30 days totaling at least $200 worth of cocaine. Cocaine use will be determined by utilizing the modified Timeline Followback, crosschecked with the ASI, which inquires about dollar amounts spent on drug use.
- Subject lives a commutable distance from the TRC and agrees to attend all research visits, including follow-up visits.
- Subject speaks, understands, and prints in English.
Key exclusion criteria (13 listed)
- Subjects mandated to treatment based upon a legal decision or as a condition of employment.
- Subjects with evidence of current substance dependence other than cocaine, alcohol or nicotine dependence, as determined by the SCID-IV.
- Subjects who meets DSM-IV criteria for current alcohol dependence who require a medical alcohol detoxification.
- Requires treatment with any psychoactive medications, including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any psychotic disorder, or organic mental disorder. Has current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).
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 |
|---|---|---|
| acamprosateAlso: Campral1998 mg/dau fpr 8 weeks | Drug | Active medication Acamprosate |
| placeboplacebo pills | Drug | Placebo |
Primary outcome
Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen
Time frame: 8 weeks
cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 acamprosate 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 13 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 10 Jul 2020. 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 31 Dec 2013). 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?
Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen (time frame: 8 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 10 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.