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

NCT00218660 | Completed Phase 3

• 3 other identifiers: NIDA-5186-1P60DA005186P60-5186-1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (4)

1

EXPERIMENTAL

Nal + BRENDA

Drug: Naltrexone; Behavioral: BRENDA

2

PLACEBO COMPARATOR

Placebo + BRENDA

Behavioral: BRENDA; Drug: Placebo

3

EXPERIMENTAL

Nal + CBT

Drug: Naltrexone; Behavioral: CBT

4

PLACEBO COMPARATOR

Placebo + CBT

Behavioral: CBT; Drug: Placebo

Interventions

Naltrexone DRUG

150mg/day Naltrexone

1; 3

BRENDA BEHAVIORAL

Psychosocial Treatment

1; 2

CBT BEHAVIORAL

Cognitive Behavioral Therapy

3; 4

Placebo DRUG

Also known as: 150mg/day Placebo

2; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.,
• 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.

You may not qualify if:

• 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. \[Note: Criteria 4-10 will be assessed via the medical exam plus results from lab tests.\]

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related Publications (3)

• 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.

  PMID: 17664051 RESULT

• 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.

  PMID: 35725670 DERIVED

• 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.

  PMID: 29452421 DERIVED

MeSH Terms

Conditions

Alcoholism; Cocaine-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Charles O'Brien, M.D., Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 1998
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: October 22, 2015

Record last verified: 2010-06

Locations

US (1)