Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Time frame

Days 1-56

Measure

NUMBER · participants

Reporting status

POSTED

Number of participants with treatment-emergent adverse events (n/% per treatment group).

Population: The population reported on is the Safety Population, which received at least one dose of active medication or placebo.

Time frame

Before dosing on Day 0 (baseline without CBD) and on Days 7 and 28 after treatment with CBD. The group means below reflect the overall group means across time points as reported from descriptive statistics in the Generalized Linear Mixed Model (GLMM).

Measure

MEAN · score on a scale

Reporting status

POSTED

Cue-induced craving was measured at baseline, Day 7, and Day 28, when participants completed a cue-induced craving task in which they viewed pictures of neutral and opioid-related cues and rated their level of opioid craving on an abbreviated (7-item) version of the Desire for Drug Questionnaire (DDQ). The DDQ is comprised of Likert-style responses ranging from 1 (strongly disagree) to 7 (strongly agree), with total scores on the 7-item scale ranging from 7 to 49, with higher scores reflecting higher craving. The measure of cue-induced craving was derived by subtracting DDQ scores following neutral cues from DDQ scores following opioid cues (range = -42 to 42), with higher scores reflecting greater craving following opioid cues than neutral cues.

Population: The analysis populaton was the Safety Population (participants who received at least one dose of test compound).

Time frame

Before dosing (Day 0), daily during treatment period (28 days), and weekly during follow-up (up to 4 weeks). Group means below reflect overall group means across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.

Measure

MEAN · score on a scale

Reporting status

POSTED

The Penn Alcohol Craving Scale (PACS) is a brief 4-item self-report measure of spontaneous alcohol craving. In the current study, the items were adapted to measure opioid craving instead of alcohol craving. Responses pertain to opioid craving in the last 24 hours and are measured on a Likert-scale (ranging from 0 to 6), with total scores ranging from 0 to 24. Higher total scores indicate higher levels of spontaneous opioid craving.

Time frame

Before dosing (Day 0), daily during treatment period (28 days), and weekly during follow-up (up to 4 weeks). Group means below reflect overall group means across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.

Measure

MEAN · score on a scale

Reporting status

POSTED

State anxiety is assessed with the 20-item self-report subscale from the 40-item Spielberger State-Trait Anxiety Inventory (STAI). The state anxiety subscale evaluates how respondents feel "now", in the present moment. All items are rated on a Likert scale from 1 ("not at all") to 4 ("very much so"), with total scores on the state anxiety subscale ranging from 20 to 80. Higher total scores indicate greater state anxiety.

Time frame

Before dosing (Day 0), daily during treatment period (28 days), and weekly during follow-up (up to 4 weeks). Group means reflect overall group means across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.

Measure

MEAN · score on a scale

Reporting status

POSTED

Negative affect is assessed using the 15-item negative affect subscale from the 30-item Positive and Negative Affect Schedule (PANAS). Each item is rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely), with total scores on the negative affect subscale ranging from 15 to 75. Higher scores reflect greater negative affect.

Of 170 participants pre-screened, 97 were ineligible. Seventy-one were screened. Of these, 36 were excluded, 35 were enrolled, and 30 started the study and received at least one dose of medication (Safety Population).