Brief Summary

The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 19, 2011

Status Verified

January 1, 2011

Enrollment Period

4 years

First QC Date

March 18, 2011

Last Update Submit

May 18, 2011

Conditions

Keywords

cocaine addiction treatment craving

Outcome Measures

Primary Outcomes (1)

  • Self-report drug craving

    One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).

    One day and one month post-treatment

Secondary Outcomes (1)

  • Drug use

    One month after the intervention

Study Arms (4)

Inderal, neutral cues

EXPERIMENTAL
Drug: Inderal

Inderal, drug cues

EXPERIMENTAL
Drug: Inderal

Placebo, neutral cues

EXPERIMENTAL
Drug: Inderal

Placebo, drug cues

EXPERIMENTAL
Drug: Inderal

Interventions

Inderal vs. placebo will be administered with or without cocaine cues

Inderal, drug cuesInderal, neutral cuesPlacebo, drug cuesPlacebo, neutral cues

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
  • Minimum of three days cocaine abstinent on study days;
  • Primary use of cocaine is intra-nasal or smoked crack

You may not qualify if:

  • Medical conditions that might be aggravated by participation in the study:
  • cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: \< 100 mmHg), bradycardia (heart rate \< 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: \> 160 mmHg; DBP: \> 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
  • respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
  • diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
  • Seropositive pregnancy test
  • Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
  • Severe liver disfunction
  • Current or recent (\< 5 half lives) use of medications that may interact with Inderal (see above)
  • Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 19, 2011

Record last verified: 2011-01