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Substance DependenceNCT00430482

Stress, Distress Intolerance, and Drug Dependence

A study testing Cognitive Behavioral Therapy and Individual Counseling in people with Substance Dependence, run by Boston University Charles River Campus at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Substance Dependence
What is being tested?
Cognitive Behavioral Therapy and Individual Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
2 sitesUnited States
Study dates
Jun 2005to Jul 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The primary selection criteria include women and men between the ages of 18 and 65 who:
  • Meet DSM-IV criteria for opiate dependence,
  • Maintain a stable dose of methadone for two weeks prior to recruitment and,
  • a) fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment, b) test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment c) have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.
  • Meet study criteria for chronic stress
  • unemployment criteria, and
  • affective disorder criteria.

Who cannot join

  • (1) Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
  • Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
  • Patients receiving medication affecting methadone metabolism (e.g. rifampin).
  • Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
  • Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Bay Cove Treatment Center

    Boston, Massachusetts, 02114

  • Habit Management Institute

    Boston, Massachusetts, 02118

Other trials in United States

About this study

This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.

Read the detailed description

This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.

Being tested
Cognitive Behavioral Therapy, Individual Counseling
Keywords
Substance Dependence, Cognitive-Behavior Therapy, Opiate Dependence, Treatment Moderators
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    Also called CBT

    12 weekly sessions and 3 booster sessions of cognitive behavioral therapy

  • Individual CounselingBehavioural

    Also called ICT

    12 weekly sessions and 3 booster sessions of individual counseling

Study groups in NCT00430482
Study groupRoleWhat they receive
1ExperimentalCognitive Behavioral Therapy
Receives: Behavioral: Cognitive Behavioral Therapy
2Active comparatorIndividual Counseling
Receives: Behavioral: Individual Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Positive Toxicology Swabs for Illicit Substances

    The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.

    Measured: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.

Secondary outcomes (1)

  1. Addiction Severity Index (ASI) Drug Composite Index

    The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.

    Measured: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430482
Sponsor's protocol ID
R01DA017904
Other IDs
R01DA017904
Status last verified
Jul 2019
First submitted
31 Jan 2007
Last updated
10 Jul 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hearon BA, Calkins AW, Halperin DM, McHugh RK, Murray HW, Otto MW. Anxiety sensitivity and illicit sedative use among opiate-dependent women and men. Am J Drug Alcohol Abuse. 2011 Jan;37(1):43-7. doi: 10.3109/00952990.2010.535581. Epub 2010 Nov 19.

    PubMed 21090958

  • McHugh RK, Murray HW, Hearon BA, Pratt EM, Pollack MH, Safren SA, Otto MW. Predictors of dropout from psychosocial treatment in opioid-dependent outpatients. Am J Addict. 2013 Jan;22(1):18-22. doi: 10.1111/j.1521-0391.2013.00317.x.

    PubMed 23398222

  • McHugh RK, Weitzman M, Safren SA, Murray HW, Pollack MH, Otto MW. Sexual HIV risk behaviors in a treatment-refractory opioid-dependent sample. J Psychoactive Drugs. 2012 Jul-Aug;44(3):237-42. doi: 10.1080/02791072.2012.703507.

    PubMed 23061323

  • Otto MW, Hearon BA, McHugh RK, Calkins AW, Pratt E, Murray HW, Safren SA, Pollack MH. A randomized, controlled trial of the efficacy of an interoceptive exposure-based CBT for treatment-refractory outpatients with opioid dependence. J Psychoactive Drugs. 2014 Nov-Dec;46(5):402-11. doi: 10.1080/02791072.2014.960110.

    PubMed 25364993

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy and Individual Counseling in people with Substance Dependence, run by Boston University Charles River Campus at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Positive Toxicology Swabs for Illicit Substances (time frame: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430482, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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