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Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1

Primary Purpose

Alcoholism, Cocaine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
BRENDA
CBT
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and females, 18-65 years old. Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID. In the past 30 days, S used no less than $200-worth of cocaine and >15 standard alcohol drinks (avg)/week with at least 1 day of 4 or more drinks, determined by the TLFB--adapted to collect daily cocaine use. Successful completion of alcohol detoxification, i.e., 5 consecutive days of abstinence from cocaine and alcohol, via self-reports and negative urine toxicology screens. Lives a commutable distance to the TRC and agrees to follow-up visits. Understands and signs the consent. Exclusion Criteria: Abstinent from cocaine or alcohol for 30 days prior to signing consent form. (S may have been institutionalized in the prior month and still be eligible if his/her cocaine and alcohol use that month met inclusion criteria.) Current DSM-IV diagnosis of any substance dependence other than cocaine, alcohol, nicotine, or cannabis determined by the SCID. Evidence of opiate use in the past 30 days, determined by self-report on the SCID or ASI, and/or by a urine drug screen that is positive for opiates at treatment entry. Current treatment with psychotropic medications (excluding short-term use of benzodiazepines for detoxification), including disulfiram. History of unstable or serious medical illness, including need for opioid analgesics. History of epilepsy or seizure disorder. Known severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, or elevated levels over 4.5x normal of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT). Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which would make it unsafe for the patient to participate in the opinion of the primary investigators. Use of an investigational medication in the past 30 days. Female Ss who are pregnant, nursing, or not using a reliable method of contraception. [Note: Criteria 4-10 will be assessed via the medical exam plus results from lab tests.]

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Nal + BRENDA

Placebo + BRENDA

Nal + CBT

Placebo + CBT

Outcomes

Primary Outcome Measures

Alcohol and Cocaine use during the treatment trial period and at the 6- and 12-month follow-up.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
October 21, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218660
Brief Title
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1
Official Title
Naltrexone and Psychosocial Treatments for the Treatment of Cocaine Dependence Complicated by Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational. We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy, CBT, is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy, BRENDA, will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.
Detailed Description
The project will use a 2x2 design to assess the efficacy of naltrexone for treating subjects who are both cocaine and alcohol dependent and who will receive either CBT or BRENDA alone or in combination with naltrexone. There will be 300 DSM-IV cocaine-alcohol dependent male and female subjects randomized to one of four groups (75 subjects per group). Subjects will be randomized to either 150mg/day naltrexone or placebo and to receive either CBT (a type of cognitive behavior therapy derived from relapse prevention principles), or a new primary-care basedmodel, BRENDA, comprised of strategies for enhancing motivation and treatment compliance. All subjects will receive one of the four combinations of medication and psychosocial treatment. The length of the study for each subject includes one week of screening/baseline assessments, 12 weeks of double-blind, placebo-controlled naltrexone treatment combined with one of two psychosocial treatments, and a 6-month and 12-month follow-up visit. Following successful completion of detoxification (abstinence from alcohol and cocaine for 7 days), informed consent will be signed, and Week 1 will be devoted to completing screening and baseline measures. In Week 2, subjects will be randomly assigned to medication/ psychosocial treatment combination. Following completion of the 12-week, double-blind treatment trial, subjects will be evaluated at 6-month and 12-months post-treatment visits.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Nal + BRENDA
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo + BRENDA
Arm Title
3
Arm Type
Experimental
Arm Description
Nal + CBT
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo + CBT
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
150mg/day Naltrexone
Intervention Type
Behavioral
Intervention Name(s)
BRENDA
Intervention Description
Psychosocial Treatment
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive Behavioral Therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
150mg/day Placebo
Primary Outcome Measure Information:
Title
Alcohol and Cocaine use during the treatment trial period and at the 6- and 12-month follow-up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and females, 18-65 years old. Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID. In the past 30 days, S used no less than $200-worth of cocaine and >15 standard alcohol drinks (avg)/week with at least 1 day of 4 or more drinks, determined by the TLFB--adapted to collect daily cocaine use. Successful completion of alcohol detoxification, i.e., 5 consecutive days of abstinence from cocaine and alcohol, via self-reports and negative urine toxicology screens. Lives a commutable distance to the TRC and agrees to follow-up visits. Understands and signs the consent. Exclusion Criteria: Abstinent from cocaine or alcohol for 30 days prior to signing consent form. (S may have been institutionalized in the prior month and still be eligible if his/her cocaine and alcohol use that month met inclusion criteria.) Current DSM-IV diagnosis of any substance dependence other than cocaine, alcohol, nicotine, or cannabis determined by the SCID. Evidence of opiate use in the past 30 days, determined by self-report on the SCID or ASI, and/or by a urine drug screen that is positive for opiates at treatment entry. Current treatment with psychotropic medications (excluding short-term use of benzodiazepines for detoxification), including disulfiram. History of unstable or serious medical illness, including need for opioid analgesics. History of epilepsy or seizure disorder. Known severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, or elevated levels over 4.5x normal of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT). Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which would make it unsafe for the patient to participate in the opinion of the primary investigators. Use of an investigational medication in the past 30 days. Female Ss who are pregnant, nursing, or not using a reliable method of contraception. [Note: Criteria 4-10 will be assessed via the medical exam plus results from lab tests.]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles O'Brien, M.D., 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 6178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17664051
Citation
Pettinati HM, Kampman KM, Lynch KG, Suh JJ, Dackis CA, Oslin DW, O'Brien CP. Gender differences with high-dose naltrexone in patients with co-occurring cocaine and alcohol dependence. J Subst Abuse Treat. 2008 Jun;34(4):378-90. doi: 10.1016/j.jsat.2007.05.011. Epub 2007 Jul 30.
Results Reference
result
PubMed Identifier
35725670
Citation
Ueland GA, Dahl SR, Methlie P, Hessen S, Husebye ES, Thorsby PM. Adrenal steroid profiling as a diagnostic tool to differentiate polycystic ovary syndrome from nonclassic congenital adrenal hyperplasia: pinpointing easy screening possibilities and normal cutoff levels using liquid chromatography tandem mass spectrometry. Fertil Steril. 2022 Aug;118(2):384-391. doi: 10.1016/j.fertnstert.2022.05.012. Epub 2022 Jun 18.
Results Reference
derived
PubMed Identifier
29452421
Citation
Ueland GA, Methlie P, Oksnes M, Thordarson HB, Sagen J, Kellmann R, Mellgren G, Raeder M, Dahlqvist P, Dahl SR, Thorsby PM, Lovas K, Husebye ES. The Short Cosyntropin Test Revisited: New Normal Reference Range Using LC-MS/MS. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1696-1703. doi: 10.1210/jc.2017-02602.
Results Reference
derived

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Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1

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