Managing Alcoholism in People Who Do Not Respond to Naltrexone

NCT00115037 | Completed Phase 4 Results DMC

• 1 other identifier: NIAAAOSL014851, 708534
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in motivating patients to greater medication adherence and may address psychosocial factors that may limit the effects of naltrexone.

Conditions

Alcoholism

Keywords

Alcoholism; alcohol abuse; therapy; drug resistance; naltrexone; patient care management; human subject

Outcome Measures

Primary Outcomes (2)

• Count of Responders and Non-responders in Phase 1

  This is the number of patients who responded to phase 1 treatment based on the definition that subjects were randomly assigned to.

  8 weeks

• Percentage of Heavy Drinking Days

  Percentage of days with heavy drinking, where heavy drinking is 4 (5) or more drinks for females (males) in a 24 hour period.

  16 weeks

Study Arms (6)

Phase 1 Liberal Response

EXPERIMENTAL

From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.

Drug: Naltrexone

Phase 1 Stringent Response

EXPERIMENTAL

From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 2 or heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.

Drug: Naltrexone

Phase 2 nalt and tele for responders

EXPERIMENTAL

Phase 2: Naltrexone and telephone counseling for responders.

Drug: Naltrexone; Behavioral: Telephone Counseling

Phase 2 nalt, MM and CBI for NR

EXPERIMENTAL

Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).

Drug: Naltrexone; Behavioral: Medication Management (MM); Behavioral: Combined Behavioral Intervention (CBI)

Phase 2 placebo, MM and CBI for NR

PLACEBO COMPARATOR

Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR)

Drug: placebo; Behavioral: Medication Management (MM); Behavioral: Combined Behavioral Intervention (CBI)

Phase 2 naltrexone for responders

EXPERIMENTAL

Phase 2: Naltrexone and TAU for phase 1 responders.

Drug: Naltrexone

Interventions

Naltrexone DRUG

100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.

Also known as: ReVia

Phase 1 Liberal Response; Phase 1 Stringent Response; Phase 2 nalt and tele for responders; Phase 2 nalt, MM and CBI for NR; Phase 2 naltrexone for responders

placebo DRUG

placebo comparer for 16 weeks in phase 2.

Also known as: placebo pill

Phase 2 placebo, MM and CBI for NR

Medication Management (MM) BEHAVIORAL

Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.

Also known as: MM

Phase 2 nalt, MM and CBI for NR; Phase 2 placebo, MM and CBI for NR

Combined Behavioral Intervention (CBI) BEHAVIORAL

45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.

Also known as: CBI

Phase 2 nalt, MM and CBI for NR; Phase 2 placebo, MM and CBI for NR

Telephone Counseling BEHAVIORAL

Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.

Phase 2 nalt and tele for responders

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Current DSM-IV diagnosis of alcohol dependence using the MINI.
• Meets the following drinking criteria as measured by the Timeline Followback (TLFB): \* drank within 30 days of randomization; \* reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk.) in a consecutive 30-day period over the 90-day period prior to intake; and \* has 2 or more days of heavy drinking (defined as over 5 drinks per day in males and over 4 drinks per day in females) in this same pre-treatment period, prior to intake.
• Prior to starting NTX, scores below 8 on the Clinical Inventory of Withdrawal from Alcohol (CIWA), and at least 3 consecutive days of abstinence (2 days abstinence will be permitted with approval by the principal investigator) directly prior to randomization, as determined by Subject report and breathalyzer measures
• Speaks, understands and prints in English.

You may not qualify if:

• Has abused or been dependent on opiates in the past 12 months, or evidence of opiate use in month prior to treatment, as assessed by subject report and intake urine drug screen. Use of prescription opioids prior to treatment entry is allowed at the discretion of the investigator. However, subjects must be free from use at the time of randomization.
• Meets DSM IV criteria for current dependence, abuse, or dependence in partial remission on any substance other than alcohol (except nicotine and marijuana). Subjects who test positive on the urine drug screen (with the exception of THC) at the initial visit (a repeat UDSis permitted in cases that are not clear. The repeat UDS should be at least 5 days after the initial test)
• Has a lifetime DSM-IV diagnosis of schizophrenia or any psychotic disorder. Has a current DSM-IV diagnosis of post-traumatic stress disorder (PTST) or bipolar disorder, or any disorder that may interfere with study participation, at the discretion of the investigator.
• Has evidence of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease that the principal investigator considers a risk to participation.
• Has taken any psychotropic medications (or disulfiram) regularly within the last seven days prior to randomization or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep). The required washout period for fluoxetine (Prozac®) is 14 days prior to randomization, and the required washout period for other psychotropic medications is 7 days prior to randomization.
• Has taken any detoxification medication on the day of randomization.
• Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the subject is of child-bearing potential.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Treatment Research Center, Chestnut Street

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Chakravorty S, Kuna ST, Zaharakis N, O'Brien CP, Kampman KM, Oslin D. Covariates of craving in actively drinking alcoholics. Am J Addict. 2010 Sep-Oct;19(5):450-7. doi: 10.1111/j.1521-0391.2010.00067.x.

  PMID: 20716308 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone; Medication Therapy Management

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; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

Overall the sample size was limited for detecting results in the second phase.

Results Point of Contact

• Title: David Oslin, MD
• Organization: UPENN

oslin@upenn.edu

215-823-5894

Study Officials

• David W. Oslin, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2005
• First Posted: June 21, 2005
• Study Start: September 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)