Brief Introductory Therapy for Opioid Dependence

Conditions

HIV Infections | Opiate Dependence

Trial Phase

Phase 2

Trial Purpose and Description

Trial Purpose

A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling.


Trial Description


The proposed study plans to compare the efficacy of behavioral drug and HIV risk reduction
counseling (BDRC) to low intensity methadone counseling during methadone maintenance
treatment. In selecting BDRC, we were guided by several considerations, including its
acceptability, suitability, feasibility, potential efficacy, and potential for rapid and
widespread dissemination in the U.S. and elsewhere. BDRC was developed to be delivered by
regular drug counselors, so that it would be relatively easy to disseminate this counseling
if it is found efficacious. BDRC combines behavioral contracting with an
Information-Motivation-Behavioral Skills (IMB) model for reducing HIV risk behaviors and
illicit drug use that is grounded in social cognitive theory and supported by empirical
findings in a number of studies and populations. The more intensive HIV risk reduction
interventions provided in BDRC, including personalized assessment of risk (i.e.,
identification of personal, social and environmental factors associated with risky
behaviors) and education and training in skill-building and self-control, may lead to
greater reductions in both drug- and sex-related HIV risk behaviors than the more limited,
brief counseling provided in LIMC, as supported by findings of a recent clinical trial with
methadone maintained patients and a meta-analysis regarding the effectiveness of HIV risk
reduction interventions during drug abuse treatment. BDRC emphasizes a medical model of
treatment for drug dependence and is highly complementary to and compatible with regular
methadone maintenance treatment.

Because early abstinence achievement is associated with longer term treatment success, BDRC
uses short-term behavioral contracts to help the patient achieve an initial period of
abstinence, take maintenance medications regularly and as prescribed, activate the patient
behaviorally, and reduce behaviors associated with HIV transmission. The accomplishment of
specific, short-term behavioral goals early in treatment promotes the patient's experience
of therapeutic success and counters the patient's belief that his/her actions will not lead
to success in accomplishing goals. Short-term behavioral goals target a limited number of
domains, including achieving an initial period of abstinence, increasing activities
(primarily vocational, social or recreational) that are not related to drug use, and
reducing HIV risk behaviors (e.g., fostering consistent condom use, avoiding casual sexual
encounters, avoiding IDU or needle or equipment sharing). BDRC teaches cognitive and
behavioral strategies for promoting behavioral change, including identifying antecedents of
drug use, needle sharing, and high risk sexual behaviors, and learning strategies to avoid
high risk situations or cope without engaging in these behaviors. Skill building exercises
(e.g., regarding condom use) are used within sessions to learn and practice new skills, and
patients are encouraged to practice these skills outside the session in their natural
environment. Based on recent findings from research in cognitive and social psychology on
message framing, the treatment also emphasizes the positive consequences of behavioral
change (e.g., the benefits of not using drugs or of maintaining a steady relationship vs.
the dangers associated with continued use or sex with multiple partners). Counselors are
trained to acknowledge the patient's efforts to change—even partial accomplishments of goals
are praised--rather than to focus on the patient's failures, which is often perceived as
criticism. Recognition of accomplishments and positively framed messages generally evoke
positive affect, which is often generalized and ascribed to the behavior in question, thus
resulting in greater adherence to recommendations. An emphasis on recognition of
accomplishments and positively-framed advice helps patients to build self-esteem and the
sense that they can change their lives for the better.

Substance abuse is thought to be associated with a range of memory and executive function
(EFs) deficits, but the majority of research support for this hypothesis comes from research
on alcohol and stimulant related disorders. The evidence of long-term cognitive deficits in
chronic opiate users is limited, nonetheless most consistently it suggests that EFs may be
affected by chronic opiate use. Because BDRC incorporates many cognitive behavioral
therapeutic techniques, includes educational and learning components and aims at improving
decision making skills of the patients, we plan to evaluate a broad range of memory and
executive functions of patients enrolled in the proposed study in order to identify common
EFs impairments, evaluate if such impairments interfere with treatment efficacy, and if
additional treatment components are necessary and can be devised in order to improve
treatment efficacy for patients with cognitive impairments. We also plan to evaluate if
cognitive performance improves during methadone maintenance treatment when combined with
BDRC and evaluate whether presence or absence of impairments are associated with
differential effects of treatments.

Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • opioid dependence

Exclusion Criteria:

  • suicide or homicide risk
  • psychiatric disorder requiring medication treatment
  • life threatening or unstable medical problems
Sponsor:
National Institute on Drug Abuse (NIDA)
Yale University
Dates:
September 2004
Last Updated:
January 15, 2014
Study HIC#:
0607001647

Clinicaltrials.gov ID: NCT00406484