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Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence (CAMPRAL)

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acamprosate
placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Male and females 18 years of age or older.
  2. Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined by The Structured Clinical Interview for DSM-IV (SCID-IV).
  3. 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.
  4. Subject lives a commutable distance from the TRC and agrees to attend all research visits, including follow-up visits.
  5. Subject speaks, understands, and prints in English.
  6. Written informed consent signed by the subject.

Exclusion Criteria

  1. Subjects mandated to treatment based upon a legal decision or as a condition of employment.
  2. Subjects with evidence of current substance dependence other than cocaine, alcohol or nicotine dependence, as determined by the SCID-IV.
  3. Subjects who meets DSM-IV criteria for current alcohol dependence who require a medical alcohol detoxification.
  4. Requires treatment with any psychoactive medications, including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
  5. 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).
  6. 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.
  7. 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.
  8. 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).
  9. 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).
  10. History of significant heart disease (an arrhythmia which required medication, angina pectoris, documented history of myocardial infarction, or heart failure).
  11. Known hypersensitivity to acamprosate.
  12. Subjects having participated in any investigational drug trial within 30 days prior to randomizing into the study.
  13. 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).

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active medication Acamprosate

Placebo

Arm Description

1998mg/day for 8 weeks

placebo pills for 8 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 6, 2006
Last Updated
June 24, 2020
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00385268
Brief Title
Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Acronym
CAMPRAL
Official Title
A Phase II, Double-Blind, Placebo-controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active medication Acamprosate
Arm Type
Experimental
Arm Description
1998mg/day for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo pills for 8 weeks
Intervention Type
Drug
Intervention Name(s)
acamprosate
Other Intervention Name(s)
Campral
Intervention Description
1998 mg/dau fpr 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen
Description
cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Pettinati, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence

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