Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

NCT01067846 | Completed Results DMC

• 2 other identifiers: 111989R21DA025243
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time. One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time. In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.

Conditions

Cocaine Addiction

Keywords

cocaine dependence; relapse prevention; computerized cognitive behavioral therapy (CBT); D-cycloserine (DCS)

Outcome Measures

Primary Outcomes (2)

• Drug Abstinence During Treatment and at Follow up Visits

  Percentage of the overall number of drug abstinences of participants measured by urine drug testing

  Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit

• Treatment Retention - Number of Visits During Treatment

  Number of treatment visits attended prior to discontinuation of treatment

  Treatment sessions included 3 visits per week for 4 weeks

Study Arms (2)

DCS and Cognitive Behavioral Therapy

EXPERIMENTAL

Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

Drug: Seromycin (D-cycloserine, DCS); Behavioral: Computerized Cognitive Behavioral Therapy

Placebo and Cognitive Behavioral Therapy

PLACEBO COMPARATOR

Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.

Drug: Placebo; Behavioral: Computerized Cognitive Behavioral Therapy

Interventions

Seromycin (D-cycloserine, DCS) DRUG

250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.

Also known as: D-cycloserine, DCS

DCS and Cognitive Behavioral Therapy

Placebo DRUG

Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.

Placebo and Cognitive Behavioral Therapy

Computerized Cognitive Behavioral Therapy BEHAVIORAL

All participants received Computerized Cognitive Behavioral Therapy sessions 3 times per week for 4 weeks as a drug relapse intervention.

DCS and Cognitive Behavioral Therapy; Placebo and Cognitive Behavioral Therapy

Eligibility Criteria

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

You may qualify if:

• Eligible subjects must be cocaine-dependent persons between 18 and 65 years

You may not qualify if:

• Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use
• Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications
• Positive history of loss of consciousness of greater than 10 min
• Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable
• History of hospitalization within the previous six months for a medical illness
• Deafness, blindness or other significant sensory impairment.
• Contraindications for D-cycloserine and magnetic resonance imaging.

Sponsors & Collaborators

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

Study Sites (1)

Psychiatric Research Institute (PRI) (Center for Addiction Research (CAR) and Brain Imaging Research Center (BIRC)) University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clint Kilts, PhD
• Organization: Brain Imaging Research Center

CDKilts@uams.edu

526-8163

Study Officials

• Clinton Kilts, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 12, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 26, 2013
• Results First Posted: November 26, 2013

Record last verified: 2013-10

Locations

US (1)