Trial Outcomes & Findings for Beta-blockade Effects on Memory for Cocaine Craving (NCT NCT00830362)

Results Overview

Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Both days of cue exposure

Results posted on

2012-11-30

Participant Flow

Individuals who met DSM-IV criteria for current cocaine dependence (within the past month) but who were not dependent on any other substance, with the exception of nicotine, served as participants. The primary method of recruitment was media advertisement (radio, local papers) which ran from January of 2009 until July of 2011.

Exclusion criteria included severe psychiatric comorbidity (e.g., psychotic disorder, bipolar disorder, severe major depressive disorder with suicidal ideation) or medical illness or use of medications that might interact with propranolol. Individuals with other substance dependence (with exception of nicotine) were also excluded at initial visit.

Participant milestones

Participant milestones
Measure	Propranolol 40mg Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.	Placebo Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
Overall Study STARTED	27	24
Overall Study Completed Sessions 1 and 2	26	24
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beta-blockade Effects on Memory for Cocaine Craving

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propranolol 40mg n=26 Participants Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).	Placebo n=24 Participants Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).	Total n=50 Participants Total of all reporting groups
Age Continuous	39.1 years STANDARD_DEVIATION 1.6 • n=5 Participants	40.8 years STANDARD_DEVIATION 2.0 • n=7 Participants	39.9 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Both days of cue exposure

Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.

Outcome measures

Outcome measures
Measure	Propranolol 40mg n=26 Participants Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).	Placebo n=24 Participants Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
Single Item Craving Test Session Difference Scores	-25.0 units on a scale Standard Error 4.5	-10.5 units on a scale Standard Error 4.7

Adverse Events

Propranolol 40mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Saladin

Medical University of South Carolina

Phone: 843-792-5306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place